The following is a list of current standards and technical reports from the ADA Standards Committee on Dental Products (SCDP). To purchase any document below, please visit the ADA Store.
ADA members receive technical reports at no charge and standards are available at a discounted rate.
This standard gives a classification of, and specifies requirements for, gypsum products used for dental purposes such as making oral impressions, molds, casts, dies or model bases, and mounting models. It specifies the test methods to be employed to determine compliance with these requirements. It also includes requirements for the labeling of packaging and for adequate instructions to accompany each package. This standard does not apply to dental bone graft substitutes composed of calcium sulfate hemihydrate (or gypsum). This standard is an identical adoption of ISO 6873:2013, Dentistry — Gypsum products.
This document specifies requirements for dental polymer-based restorative materials supplied in a form suitable for mechanical mixing, hand-mixing, or intra-oral and extra-oral external energy activation, and intended for use primarily for the direct or indirect restoration of the teeth and for luting.
The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges. This document does not cover those polymer-based luting materials that have an adhesive component within the structure of the material (see ISO/TS 16506).
The document does not cover polymer-based materials intended to prevent caries (see ANSI/ADA Standard No. 39/ISO 6874), core materials or those used for veneering metal sub-frames (see ANSI/ADA Standard No. 53/ISO 10477).
It is an identical adoption of ISO 4049:2019.
This document specifies requirements and test methods for hand-held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in ANSI/ADA Standard No. 63, ANSI/ADA Standard No. 71, ANSI/ADA Standard No. 95, or ANSI/ADA Standard No. 101. This document specifies requirements for size, marking, product designation, safety considerations, labeling and packaging. This standard is an identical adoption of ISO 3630-5:2020, Dentistry-Endodontic requirements-Part 5:Shaping and cleaning instruments.
This document specifies requirements for zinc oxide-eugenol cements suitable for use in restorative dentistry for temporary cementation, for bases and as temporary restorations.
This document also specifies requirements for non-eugenol zinc oxide cements containing zinc oxide and oil(s) other than eugenol for temporary cementation.
It is an identical adoption of ISO 3107:2022.
This standard specifies requirements and test methods for wires to be used in fixed and removable orthodontic appliances. It includes preformed orthodontic archwires but excludes springs and other preformed components. This standard gives detailed requirements concerning the presentation of the physical and mechanical properties of orthodontic wires, the test methods by which they can be determined, and packaging and labeling information. This standard is an identical adoption of ISO 15841:2014, Dentistry — Wires for use in orthodontics.
This document defines terms used in dental product standards. This document aims to facilitate the standard development process and the comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in standardization. This standard is an identical adoption of ISO 1942:2020.
This standard specifies requirements and test methods for dental cartridge syringes which are reusable dental
syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local anesthetics.
This standard is not applicable to cartridge syringes having a mechanical-advantage action for creating high
pressure. This standard is an identical adoption of ISO 9997:1999, Dental cartridge syringes.
This document specifies requirements and test methods for handpieces and motors used in dentistry for treatment of patients and having patient contact, regardless of their construction. It also specifies requirements for manufacturer’s information, marking and packaging.
This document is applicable to the following:
This document is not applicable to the following:
It is an identical adoption of ISO 14457:2017.
This standard is for powdered abrasive materials used in dentistry for removing stains and gross scratches from natural tooth structures and prostheses but not including materials used in laboratory blasting processes. These materials are divided into types depending on the intended manner of use and further sub-divided into classes based upon the predominant abrasive agent present in the product.
This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations. This document applies only to the materials used in combination. Conformity cannot be claimed for a single material.
For requirements for ceramic materials, see ANSI/ADA Standard No. 69 or ISO 6872. For requirements for metallic materials see ANSI/ADA Standard No. 134 or ISO 22674. This standard is an identical adoption of ISO 9693:2019.
This standard specifies requirements and test methods for resin-based materials suitable for sealing pits and fissures in teeth. This standard covers both chemically cured and external-energy-activated materials. This standard is an modified adoption of ISO 6874:2015, Dentistry — Polymer-based pit and fissure sealants.
This standard specifies test methods for the evaluation of biological effects of medical devices used in dentistry. It includes testing of pharmacological agents that are an integral part of the device under test. This document does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body. This standard is a modified adoption of ISO 7405:2018.
This document specifies requirements for electrically-powered mixing machines for mixing dental amalgam alloy, and dental mercury in capsules to produce dental amalgam. This document specifies the test methods used to determine conformity with these requirements. This document refers to those machines that mix by an oscillating action and which are sold by the manufacturer for the purpose of mixing dental amalgam whether or not they are intended for mixing any other type of product. This document does not specify requirements for removable mixing-capsules, as are used in many machines to contain the material to be mixed, although considered as part of the machine when in use or under test. This standard is an identical adoption of ISO 7488:2018.
This document specifies requirements and test methods for stationary dental units, dental patient chairs, and combinations of both regardless of whether they are or not electrically powered. This document also specifies requirements for the instructions for use, for the technical description, for marking and for packaging. Operator's stools, portable dental equipment and operating lights are not in the scope of this document. This standard is a modified adoption of ISO 7494-1:2018.
This document specifies requirements and test methods concerning:
a) the configuration of dental unit connections to the compressed air supply, water supply, suction supply, and wastewater drain plumbing,
b) the materials, design, and construction of the compressed air and water system within the dental unit,
c) the quality for incoming water and air, and
d) the performance of dental unit suction system.
This document also specifies requirements for instructions for use and technical description. This document is limited to dental units that are not used for life support treatment of ambulatory patients or for oral surgery treatment requiring sterile air and water supplies. Amalgam separators are not included in this document.
This standard is a modified adoption of ISO 7494-2:2015.
This document specifies requirements and test methods for powered polymerization activators in the 380 nm to 515 nm wavelength region intended for chairside use in polymerization of dental polymer-based materials. This document applies to quartz-tungsten-halogen lamps and light-emitting diode (LED) lamps. Powered polymerization activators could have internal power supply (rechargeable battery powered) or be connected to external (mains) power supply. Lasers or plasma arc devices are not covered by this standard. This document does not cover powered polymerization activators used in laboratory fabrication of indirect restorations, veneers, dentures or other oral dental appliances.
This standard is a identical adoption of ISO 10650:2018 Dentistry — Powered polymerization activators.
This document classifies polymer-based crown and veneering materials used in dentistry and specifies their requirements. It also specifies the test methods to be used to determine conformity to these requirements.
This document is applicable to polymer-based crown and veneering materials for laboratory-fabricated permanent veneers or crowns. It also applies to polymer-based dental crown and veneering materials for which the manufacturer claims adhesion to the substructure without macro-mechanical retention such as beads or wires.
It is an identical adoption of ISO 10477:2020.
This standard covers sterile, single-use, individually-packaged, double-pointed needles with a means of secure attachment to cartridge-type syringes used for dental, regional, anesthetic injections.
This standard specifies requirements and test methods for endodontic sealing materials, which set with or without the assistance of moisture and are used for permanent obturation of the root canal with or without the aid of obturating points/cones. It covers materials intended for orthograde use i.e. a root filling placed from the coronal aspect of a tooth. Additionally, the methods can be used to test retrograde materials.
This standard is a modified adoption of ISO 6876:2012, Dentistry – Root canal sealing materials.
This standard specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures not cited in ANSI/ADA Standard Nos. 28, 71, 95 or 101. It also specifies requirements for size, product designation, safety considerations, instructions and labeling.
This standard is a modified adoption of ISO 3630-4:2009 Dentistry – Root canal instruments – Part 4: Auxiliary instruments.
This standard specifies the requirements and the corresponding test methods for dental ceramic materials for fixed all-ceramic and metal-ceramic restorations and prostheses.
This standard is an identical adoption of ISO 6872:2015, Dentistry – Ceramic materials and ISO 6872:2015/Amd. 1: 2018.
This document specifies the requirements and test methods for endodontic compactors (pluggers and spreaders) which are used for the compaction of endodontic filling materials, and also heat-carriers (which are not specified in the other parts of the ISO 3630 series).
This document specifies the requirements for size, marking, product designation, safety considerations, and their labelling and packaging.
It is an identical adoption of ISO 3630-3:2021.
This standard specifies requirements and test methods for nonmedicated absorbent points used in endodontic procedures. For the purposes of this document, points refer to dental absorbent points. The requirements apply to points which have been sterilized once in a manner approved by the manufacturer. Points include standard and taper sized points. This standard does not specify requirements or test methods for sterility and/or freedom from biological hazard of points.
This standard is a modified adoption of ISO 7551:1996, Dental absorbent points.
This standard sets forth requirements, recommendations and test methods for the operator's stool in the dental office as well as requirements for the manufacturer's instructions for use and for marking and packaging. It also covers recommendations to manufacturers on the design of operator's stools. This standard is a modified adoption of ISO 7493:2006, Dentistry-Operator's stool.
This document specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis. This document is an identical adoption of ISO 10139-1:2018.
This document establishes the specifications for the dimensions of various endodontic obturating materials including preformed metal, preformed polymeric-coated metal, polymeric points, thermoplastic obturating material or combinations of the above, suitable for use in the obturation of the root canal system. This document also specifies numerical systems and a color-coding system for designating the sizes of preformed endodontic obturating points.
Dental endodontic obturating points are marketed sterilized or non-sterilized. This document covers the physical attributes expected of such products as supplied.
It is an identical adoption of ISO 6877:2021.
This standard specifies a procedure for determining the color stability of dental materials after exposure to light or water. This standard is an identical adoption of ISO 7491:2000, Dental Materials—Determination of Color Stability.
This standard applies to reusable and disposable impression trays used in dentistry for delivering impression materials into the oral cavity for the purpose of making impressions (negative copies) of teeth and oral tissues. It applies to trays made of plastic, aluminum, stainless steel and nickel or chrome plated brass for the purposes of full arch dentulous or edentulous, partially edentulous, partial arch and water cooled impressions.
This document specifies requirements and test methods for operating lights used in the dental office and intended for illuminating the oral cavity of patients. It also contains specifications on the instructions for use, marking and packaging.
This document applies to operating lights, irrespective of the technology of the light source.
This document excludes auxiliary light sources, for example, from dental handpieces and dental headlamps and also operating lights which are specifically designed for use in oral surgery.
It is an identical adoption of ISO 9680:2021.
This document specifies requirements and test methods for central compressed air source equipment supplying dental air for dental units and various dental air consuming devices in the dental office. It also specifies quality requirements and test methods for the dental air produced by the central compressed air source equipment, such as requirements for the purity level of dental air. It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central compressed air source equipment.
This document applies only to central compressed air source equipment located outside of the dental treatment room. This document does not apply to central compressed air source equipment located in the dental treatment room and facility piping. This document does not include requirements for dental laboratory applications (e.g. CAD/CAM systems). This standard is an identical adoption of ISO 22052:2020.
This standard specifies requirements for enlargers not cited in ANSI/ADA Standard No. 28, ANSI/ADA Standard No. 63, ANSI/ADA Standard No. 71, or ANSI/ADA Standard No. 101.
This standard specifies requirements for size, marking, product designation, safety considerations, and their labeling and packaging, including the instructions for use. This standard is a modified adoption of ISO 3630-2:2013 Dentistry – Endodontic instruments – Part 2: Enlargers.
Part 1 of ADA Standard No. 96 specifies requirements and test methods for powder/liquid acid-base dental cements intended for permanent cementation, lining and restoration. Part 1 is applicable to both hand-mixed and capsulated cements for mechanical mixing. Part 1 specifies limits for each of the properties according to whether the cement is intended for use as a luting agent, a base or liner or as a restorative material. Part 1 of this standard is not intended to address resin-modified water-based cements, which are addressed in Part 2. This standard is a modified adoption of ISO 9917-1:2007, Dentistry — Water-based cements - Part 1: Powder/liquid acid-base cements and ISO 9917-2:2017, Dentistry – Water-based cements - Part 2: Resin-modified cements.
This document specifies test methods and procedures to determine the corrosion behavior of metallic materials used in the oral cavity. It is intended that these test methods and procedures be referred to in individual standards specifying such metallic materials.
This document is not applicable to dental instruments.
It is an identical adoption of ISO 10271:2020.
This specification is for thermoplastic or thermosetting polymeric materials, with or without a polymeric shell, that are capable of being formed into an athletic mouth protector, either on a model of the teeth or in the mouth directly on the teeth. It lists the types and classes of mouth protectors and lists requirements for physical properties along with tests specified for determining compliance with those requirements It also specifies requirements for manufacturer's instructions and for packaging, labeling, and marking.
This document specifies requirements and test methods to compare the functional dimensions of orthodontic brackets and tubes and their chemical ion release, as well as packaging and labeling information.
This document is applicable to brackets and tubes for use in fixed orthodontic appliances. This standard is an identical adoption of ISO 27020:2019 Dentistry – Brackets and tubes for use in orthodontics.
This document specifies general requirements and test methods for endodontic instruments used for endodontic purposes, e.g. enlargers, compactors, accessory instruments, shaping and cleaning instruments, and a numeric coding system. In addition, it covers general size designations, color-coding, packaging, and identification symbols. This standard is an identical adoption of ISO 3630-1:2019, Dentistry — Endodontic Instruments — Part 1: General Requirements.
This standard is applicable to all elastomeric auxiliaries including orthodontic elastics, elastomeric bands, chains, links, thread and ligatures used for orthodontics both inside and outside the mouth, in conjunction with fixed and removable appliances.
This standard is a modified adoption of ISO 10271:2011.
This standard specifies requirements and test methods for amalgam separators used in connection with dental equipment in the dental treatment center. It specifies the efficiency of the amalgam separators in terms of the level of retention of amalgam based on a laboratory test and the test procedure for determining this efficiency. It also includes requirements for the safe functioning of the amalgam separator, for marking, and for instructions for use, operation and maintenance. All tests described in this standard are type tests. This standard is an identical adoption of ISO 11143:2008, Dentistry – Amalgam separators.
This standard describes procedures for storing, and preparing amalgam waste for delivery to recyclers or their agents for recycling. In addition, it gives requirements for the containers for storing and/or shipping amalgam waste.
This standard gives guidance on substrate selection, storage, and handling as well as essential characteristics of different test methods for quality testing of the adhesive bond between restorative dental materials and tooth structure, i.e. enamel and dentine. It includes a tensile bond strength measurement test, a test for measurement of marginal gaps around fillings, a microleakage test, and gives guidance on clinical usage tests for such materials. Some specific test methods for bond strength measurements are given for information in Annex A. This standard does not include requirements for adhesive materials and their performance.
This standard specifies the general material, performance, and dimensional requirements for periodontal curettes, dental scalers and excavators. This standard is a modified adoption of ISO 13397-1:1995, Periodontal curettes, dental scalers and excavators – Part 1: General requirements; ISO 13397-2:2005, Dentistry – Periodontal curettes, dental scalers and excavators – Part 2: Periodontal curettes of Gr-type; and ISO 13397-2/Amendment 1:2012, Color coding.
This document specifies general requirements and test methods for portable dental equipment for use in non-permanent healthcare environments.
Portable dental equipment within the scope of this document includes portable dental units, portable patient chairs, portable operator’s stools, portable operating lights, portable suction source equipment, portable air compressors and other portable dental equipment in instances where these devices are designed and constructed to be transported for use in non-permanent healthcare environments.
It is an identical adoption of ISO 23402-1:2020.
This standard defines physical and chemical requirements and test methods for oral rinses. It also specifies the accompanying information such as manufacturer's instructions for use, marking and/or labeling requirements. This standard is not applicable to other delivery systems (e.g. mouthsprays, foams, powders). It is not intended to describe regulatory aspects, e.g. methods of prescription. This standard is not applicable to oral rinses available by prescription only. This standard is a modified adoption of ISO 16408:2015, Dentistry – Oral hygiene products – Oral rinses.
This document specifies requirements and test methods for total digestible fluoride content and a minimum soluble fluoride release potential in dental varnishes containing fluoride, intended for use in the oral cavity directly on the outer surfaces of teeth and fillings. It also specifies packaging and labeling requirements, including the instructions for use. This document covers fluoride varnishes to be applied by dental health care workers.
This standard is an identical adoption of ISO 17730:2020.
This document specifies requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.
This document does not specify any requirements and test methods for the physical properties of toothbrushes for which all the cleaning elements in the head are elastomer.
This document does not apply to manual single tuft toothbrushes, single use, interdental and powered oral hygiene devices. These types of oral hygiene products are evaluated for their safety in-use by appropriate test methods or clinical trials.
In addition, for the filaments end-rounding requirements, this document does not apply to particular filament types which are very thin (less than 0.1 mm outside diameter) or have no sharp edges (e.g. tapered, feathered, with split tips, or spherical cap) or non-synthetic filaments, where applying end-rounding process is inappropriate or impossible. These types of manual toothbrushes are evaluated for their safety in-use by appropriate test methods or clinical trials appropriately.
It is an identical adoption of ISO 20126:2022.
This document specifies requirements and test methods for the physical properties of powered toothbrushes in order to promote the safety of these products for their intended use.
There are different technologies of powered toothbrushes. Common features of those powered toothbrushes to which this document applies are:
— a battery;
— a motor;
— a mechanical or magnetic drive system;
— a moving brush head with tufted filaments.
Powered toothbrushes can have a moving brush head with different motions (e.g. oscillating-rotating, side-by-side), frequencies and velocities. The requirements listed in this document apply to all types of powered toothbrushes. However, there is a possibility that some requirements are not applicable for all types, for example brush head plate retention can only be applied if the brush has a head portion that might get detached from the brush shaft. This document is not applicable to other types of powered oral hygiene devices (such as powered interdental brushes) or manual toothbrushes.
This standard is an identical adoption of ISO 20127:2020.
This document specifies the classification of and requirements for dental casting and dental baseplate waxes together with the test methods to be employed to determine compliance with these requirements.
This document does not apply to waxes supplied for additive manufacturing or CAD/CAM-based procedures.
It is an identical adoption of ISO 15854:2021.
This standard specifies requirements and test methods for performance criteria for manual interdental brushes with a round cross-section of the brush head and consisting of a wired stem with inserted filaments. It also specifies the accompanying information such as manufacturer’s instructions for use and labeling of the packaging. Excluded are interdental brushes with a plastic core. This standard is not applicable to powered interdental brushes, manual toothbrushes, dental floss, tapes, and strings and to interdental cleaners that do not include filaments. This standard is an identical adoption of ISO 16409:2016 Dentistry – Oral Care Products – Manual Interdental Brushes.
This standard gives requirements and test methods for determining the compliance of dental casting investment, dental brazing investment, dental pressable-ceramic investment and dental refractory die materials used in the dental laboratory, regardless of the composition of the refractory powder, the composition of the binder, or the particular application.
This standard classifies such products into types and classes, according to their intended use and the burn-out procedure recommended by the manufacturer. It also gives requirements for marking, labeling and manufacturer’s instructions. It specifies requirements for the essential physical and mechanical behaviors of the products and the test methods to be used for determining them. This standard is an identical adoption of ISO 15912:2016.
This standard specifies a method of dynamic testing of single post endosseous dental implants of the transmucosal type in combination with their premanufactured prosthetic components. It is most useful for comparing endosseous dental implants of different designs or sizes. This International Standard is not a test of the fundamental fatigue behavior of the materials from which the endosseous implants and prosthetic components are made. This standard is not applicable to dental implants with endosseous lengths shorter than 8 mm nor to magnetic attachments. This standard is an identical adoption of ISO 14801:2016, Dentistry - Implants - Dynamic loading test for endosseous dental implants.
This document specifies the requirements and test methods for hydrocolloid impression materials. This document helps to determine whether elastic aqueous agar and alginate hydrocolloid dental impression materials, as prepared for retail marketing, are of the quality needed for their intended purposes. It also specifies requirements for labelling and instructions for use.
It is an identical adoption of ISO 21563:2021.
This document specifies requirements for the physical and chemical properties of dentifrices and provides guidelines for suitable test methods. It also specifies requirements for the marking, labeling and packaging of dentifrices. This document applies to dentifrices, including toothpastes, destined to be used by the consumers on a daily basis with a toothbrush to promote oral hygiene.
This standard describes test methods used to evaluate the repeatability, reproducibility and accuracy of dental devices for 3D metrology. The standard is applicable to dental chairside and dental laboratory CAD/CAM systems. The scope of this document is not intended to include unique systems with other specific applications of 3D metrology in the dental field such as 3D computed tomography, magnetic resonance imaging and stereophotogrammetry.
Presently, the number of devices emitting light energy, and the range of procedures they are performing, is expanding at an extraordinary rate. The focus of this technical report is to provide basic information on the use of lasers in dentistry and to facilitate the appropriate selection of the necessary equipment. This report further seeks to provide scientific information and a fundamental understanding on how light energy in the visible and thermal ranges of the electromagnetic spectrum interacts with biologic structures.
Additionally, this technical report provides an elementary understanding of potential hazards and laser safety considerations that need to be addressed when lasers are used in the dental environment. Laser safety is comprehensively addressed in the American National Standard Z136 documents on laser safety. It is strongly recommended that all dental facilities using lasers and light based treatment modalities, or are planning to, obtain the most current version of the American National Standard Z136.1 for the Safe Use of Lasers and the American National Standard Z136.3 for the Safe Use of Lasers in Healthcare available from the Laser Institute of America (LIA) at www.LIA.org.
This document specifies requirements and test methods for metallic materials that are suitable for the fabrication of dental restorations and appliances. Included are metallic materials recommended for use either with or without a ceramic veneer, or recommended for both uses. Furthermore, this document specifies requirements for packaging and marking of the products and for the instructions for use of these materials, including products delivered for sale to a third party.
It is an identical adoption of ISO 22674:2022.
This standard classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This standard classifies denture adhesives used by wearers of removable dentures; it also specifies requirements, test methods and instructions to be supplied for the use of such products. This standard is an identical adoption of ISO 10873:2010, Denture adhesives.
This document specifies the requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and manufacturer’s instructions for use.
This document is not applicable to tooth bleaching products:
This document does not specify biological safety aspects of tooth bleaching products.
It is a modified adoption of ISO 28399:2021.
This standard is a modified adoption of ISO 20795-1:2013 Dentistry — Base polymers — Part 1:Denture base polymers and ISO 20795-1:2013 Dentistry — Base polymers — Part 2: Orthodontic base polymers.
The standard is presented in two parts: 1) Denture-base polymers and 2) Orthodontic-base polymers. Part 1 classifies denture base polymers and copolymers and specifies their requirements. It also specifies the test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials. Furthermore, it applies to denture base polymers for which the manufacturer claims that the material has improved impact resistance. It also specifies the respective requirement and the test method to be used. Part 2 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.
This standard specifies requirements and tests for the duplicating materials used in dentistry which are primarily intended for forming flexible molds needed to produce positive refractory investment copies of properly blocked-out master models. This standard is an identical adoption of ISO 14356:2003, Dentistry – Duplicating material.
This technical report describes methods used to produce repeatable, predictable, and accurate digitally produced surgical guides and maxillofacial prosthetic appliances and is applicable for both dental digital data capture and dental laboratory CAD/CAM (computer-aided design/computer-aided manufacturing) systems.
Other fabricated guide devices using CAD/CAM and Cone Beam Computed Tomography (CBCT) may include, but are not limited to, guide devices for facilitated placement of temporo-mandibular joint components and surgical or prosthetic maxillofacial reconstruction procedures. This standard includes the manufacture of fully or partially assisted CAD/CAM produced maxillofacial prosthetic appliances using similar technologies.
This technical report provides guidance for successful cementation and/or bonding of CAD/CAM fabricated restorations. Restorative materials covered in this report include composites and/or hybrid ceramics, metals, oxide ceramics (zirconia and alumina), and silica-based ceramics (glass-ceramics).
the user in capsules, pre-dosed with dental amalgam alloy and dental mercury in quantities suitable for the creation of a single dental restoration. This document specifies the requirements and test methods for dental amalgam alloys that are suitable for the preparation of dental amalgam and the capsule, together with the requirements and test methods for that dental amalgam and the requirements for packaging and marking. This standard is an identical adoption of ISO 20749:2017, Dentistry —Pre-capsulated dental amalgam.
CAD/CAM abutments have an anatomically correct emergence profile and restoration substructure specific to the patient (i.e. patient specific). This technical report provides references for test methods that can be used for assessing reliability, accuracy and reproducibility of patient specific CAD/CAM abutments designed for use with a manufacturer’s own implants or for use with implants from other manufacturers; as well as guidelines for standardization of future products. The abutment is individually designed by a laboratory or doctor to be attached to an implant by means of an abutment screw, dental cement or friction fit. This document provides on abutments where milling is done at a central milling facility, a dental lab, or by an in-office milling machine.
This standard specifies a test method using a constraint-variable instrument, designed based on first principles of mechanics for the necessary accuracy and sensitivity of the instrument to the presence of shrinkage, for the measurement of polymerization shrinkage stress (PSS) of external- or internal-energy activated polymer-based restorative materials such as composites and core materials. The instrument provides the measurement carried out under various instrumental compliances that are comparable to the compliances of clinically prepared tooth cavities. This standard specifies a test method using a constraint-variable instrument, designed based on first principles of mechanics for the necessary accuracy and sensitivity of the instrument to the presence of shrinkage, for the measurement of polymerization shrinkage stress (PSS) of external- or internal-energy activated polymer-based restorative materials such as composites and core materials. The instrument provides the measurement carried out under various instrumental compliances that are comparable to the compliances of clinically prepared tooth cavities.
This standard specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues. The results of the screening method are intended for use in enamel and/or dentine erosion models. This standard is an identical adoption of ISO 28888:2013, Dentistry — Screening method for erosion potential of oral rinses on dental hard tissues.
This standard specifies requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips, including piezo, ferrostrictive and magnetostrictive type ultrasonic scalers, operated as stand-alone items or connected to dental units, for use on patients. It also contains specifications on manufacturers’ instructions, marking and packaging.
This standard is a modified adoption of ISO 18397:2016 Dentistry — Powered scaler.
This standard specifies the coupling between handpieces and motors connected to dental units. This standard specifies the nominal dimensions, tolerances and the extraction force of coupling systems for use between handpiece and motor which supply the handpiece with water, air and light and rotation energy.
This standard is a modified adoption of ISO 3964:2016, Dentistry – Coupling dimensions for handpiece connectors and ISO 3964:2016/Amendment 1:2018.
This standard applies to coiled springs for use in orthodontic appliances. This standard gives details of methods to compare the physical and mechanical behavior of coiled springs, the test methods by which they can be determined, as well as packaging and labeling requirements. This standard is an identical adoption of ISO 17254:2016, Dentistry — Coiled springs for use in orthodontics.
This standard specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.
This standard is an identical adoption of ISO 10139-2:2016.
This standard identifies three types of topics related to shade conformity and interconvertibility of monochromatic and polychromatic tissues and materials related to the discipline of dentistry; it describes visual and instrumental methods for assessment of these topics. This standard suggests interpretation of the findings through color difference thresholds and provides guidelines for future standardization related to dental shade conformity and interconvertibility. It also includes guidelines related to color vision of persons undertaking visual color assessments and instructions for reporting of color and color difference assessments. This standard is an identical adoption of ISO/TR 28642:2016, Dentistry — Guidance on colour measurement.
This standard specifies a test method for the calibration of dental furnaces that are suitable for the heat treatment of silica-based dental ceramic restorations in the temperature range between 600 °C and 1,050 °C. This standard does not include furnaces intended to sinter zirconium oxide-frameworks (in the temperature range of 1 350°C or higher). Identical adoption of ISO 13078:2013 Dentistry—Dental furnace - Test method for temperature measurement with separate thermocouple.
This document determines a degree of firing to be implemented by the user. It represents a test method for adapting the firing program of a dental furnace by determining the degree of firing of fired test specimens for a dental ceramic. The test method is suitable for powdered dental ceramics, according to ISO 6872, Type I. The test method enables monitoring of the temperature control in the dental furnace by evaluating the firing degree of a dental ceramic. The test method is also suitable for evaluating the reproducibility of the firings in a dental furnace or for comparing several dental furnaces. This standard is an identical adoption of ISO 13078-2:2016 Dentistry — Dental furnace - Part 2: Test method for evaluation of furnace programme via firing glaze.
This document provides type test methods for evaluating the effectiveness of treatment methods intended to prevent or inhibit the formation of biofilm or to remove biofilm present in dental unit procedural water delivery systems under laboratory conditions.
This document does not apply to devices intended to deliver sterile procedural water or sterile solution. It also does not apply to lines, tubing, or hoses that deliver compressed air within the dental unit.
This document does not establish specific upper limits for bacterial contamination or describe test methods to be used in clinical situations. It also does not establish test methods for evaluating any deleterious side effects potentially caused by treatment methods.
The test methods provided in this document can be used to test other dental equipment that delivers non-sterile water to the oral cavity and products intended for the prevention, inhibition or removal of biofilm that may not be provided by dental unit manufacturers.
This standard is a modified adoption of ISO 16954:2015 Dentistry — Test methods for dental unit waterline biofilm treatment.
This technical report provides guidance on the development of cleaning processes for dental instruments, and their validation, as one of the steps in a multi-step instrument reprocessing procedure. It applies to cleaning prior to initial use as well as reuse. Validated cleaning processes are important in achieving consistently clean and biocompatible instruments, thereby mitigating the risk of cross contamination.
This technical report does not address the disinfection, inspection and sterilization steps of reprocessing dental instruments.
This standard specifies general requirements and test methods for periodontal probes. This standard specifies general requirements and test methods for periodontal probes. It is not applicable to periodontal probes with working ends made completely of plastics, nor to HAUER probes and periodontal probes with a defined probing force. This standard is an identical adoption of ISO 21672-1:2012, Dentistry — Periodontal probes - Part 1: General requirements.
This standard specifies the dimensions for dental excavators with discoid working ends. This standard is an identical adoption of ISO 13397 - 4: 1997, Periodontal curettes, dental scalers and excavators - Part 4: Dental excavators - Discoid type.
This document specifies test methods for the quantification of fluoride concentrations in dental products including dentifrices, gels, oral rinses, fluoride releasing varnishes, and other fluoride containing products. The methods are based on fluoride ion-selective electrode technology for the analysis of fluoride in aqueous samples derived from dental products. This standard is an identical adoption of ISO 19448:2018, Dentistry — Analysis of fluoride concentration in aqueous solutions by use of fluoride ion-selective electrode.
This standard specifies the minimal data set to be recorded for a patient receiving dental implant treatment. This will comprise the locations and types of dental implant bodies, connecting components and adjunctive devices, including grafting materials, placed in a patient’s jaw(s). This information will be recorded by the responsible clinician in the patient's file and should be made available to the patient by the clinician(s) who provided the care. This standard is an identical adoption of ISO 16498:2013, Dentistry — Minimal dental implant data set for clinical use.
This standard provides a system for designating the location of an implant body within a jaw, and is intended for use with the scheme described in ISO 3950. It does not in itself indicate whether the device is visible within the oral cavity or the presence of transmucosal components or implant restorations. Since the system describes location but not restoration form, it is not necessary to use the quadrant designation numbers 5 to 8 which are employed when indicating a primary tooth.This information should be recorded by the responsible clinician in the patient’s file and made available to the patient by the clinician(s) who provided the care. This standard is an identical adoption of ISO 19429:2015, Dentistry — Designation system for dental implants.
This standard specifies requirements and test methods for stationary, electrically powered central suction source equipment, including centrally located amalgam separators and air water separators. It also specifies requirements for information to be supplied by the manufacturer on the performance, installation, operation and maintenance of the central suction source equipment as part of the complete dental suction system. This standard specifies requirements for central suction source equipment used to provide vacuum pressure and flow at the facility pipeline connection point. This standard does not apply to portable suction source equipment, air/water venturi suction source equipment, or to suction source equipment located in the treatment room. It also does not apply to suction source equipment used for life support or for scavenging halogenated anaesthetic gases. This standard is an identical adoption of ISO 10637:2018, Dentistry — Central suction source equipment.
This document specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. This document gives details of methods to compare physical and mechanical properties of orthodontic anchor screws together with test methods and packaging and labeling information. This standard is an identical adoption of ISO 19023:2018, Dentistry — Orthodontic anchor screws.
This document specifies the requirements for dimensions and material properties of shanks used in dentistry for rotary or oscillating instruments. It describes the measurement methods for the verification of the requirements. This document is not applicable to tips fixed to the handpiece with a screw, e.g. scaler tips. This standard is an identical adoption of ISO 1797:2017, Dentistry — Shanks for rotary and oscillating instruments.
This document specifies a test method for bonding of polymer teeth to denture base materials. This test method is not designed to prove the properties of polymer teeth and denture base materials. This standard is an identical adoption of ISO/TS 19736:2017.
This document specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections.
It specifies requirements for cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes.
This document is an identical adoption of ISO 21533:2018.
This document specifies requirements and test methods for laser welding and the filler materials thereto used in the dental laboratory for welding of metallic restorations and appliances.
For filler materials used in laser welding, this document also specifies the information given in the instructions for use, marking and labeling.
This document is an identical adoption of ISO 28319:2018.
This document specifies the requirements and test methods for integrated dental floss and handles used for home care, community care, professional care of oral health or a part of dental treatment.
This document is applicable to integrated dental floss and handles for manual use. It does not include dental floss and handles which contain a continuous supply of dental floss, or handles to which the floss is subsequently added.
This document is an identical adoption of ISO 28158:2018.
This standard gives specific performance requirements for single-use dental cartridges of 10 ml, 1.7 ml, 1.8 ml and 2.2 ml nominal capacity for use with local anaesthetics.
It specifies tests for leakage, plunger movement, extractable volume and underfilling, and lists general overall dimensions to ensure that the cartridge will fit dental cartridge syringes complying with ANSI/ADA Standard No. 34 and ANSI/ADA Standard No. 183. Labeling requirements are also specified.
This document is an identical adoption of ISO 11499:2014.
This document specifies requirements and test methods for reusable intra-oral mirrors with a coated glass reflecting surface used for dental purposes in the oral cavity.
In addition, specific requirements for metallic casing and metallic handles are given.
This document is an identical adoption of ISO 9873:2019.
This document specifies requirements for tooth-like color representations made of ceramic materials used to determine the tooth color in the patient’s mouth or to check the color of dental prosthesis, which are referred to as color tabs in this document.
The color coordinates of color tabs are left to the manufacturers’ discretion.
Resources for visualizing the colors of ceramic and other masses, e.g. mass shade guides and color patterns for certain ceramic and other masses, do not fall into the scope of this document. They can be manufactured from any materials and serve solely to illustrate the color effect; they do not serve to determine color inside the mouth.
It is an identical adoption of ISO 22598:2020.
This document specifies general requirements and test methods for metallic dental tweezers of the Meriam type and for College type. This document is not applicable to anatomical tweezers and surgical tweezers.
It is an identical adoption of ISO 15098:2020.
This document specifies stainless steel commonly used in manufacturing dental instruments.
It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system.
This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crowns, bridges, implants) or to devices and instruments not made of stainless steel.
It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.
It is an identical adoption of ISO 21850-1:2020.
This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures. It specifies shapes and dimensions as well as information for marking.
It is a modified adoption of ISO 22570:2020.
This document specifies requirements, test methods, instructions for use and marking for multifunction handpieces (colloquially called “syringes”) intended to be used in the oral cavity of the patient.
This document does not apply to dental handpieces and motors, intraoral cameras, dental polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces, suction cannulas and saliva ejectors.
It is an identical adoption of ISO 22569:2020.
This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.
It is an identical adoption of ISO 13017:2020.
This standard specifies test methods for determining the resistance to chemical disinfectants of all materials used for external surfaces of dental equipment intended for such disinfection.
Three test methods are specified: an immersion test, a spray test and a contact test. The choice of test method to be used is left to the discretion of the party conducting the testing.
This standard does not address the bactericidal, virucidal and fungicidal effectiveness of the disinfectants.
This standard does not provide for testing the possible detrimental effects of applied stress on the resistance of test materials to the test reagents.
It is an identical adoption of ISO 21530:2004.
This recommended practice provides guidelines for decontamination and dry heat sterilization procedures used in dentists’ and physicians’ offices, laboratories, ambulatory care clinics, and other health care facilities. These guidelines are intended to promote the assurance of sterility by identifying the special considerations that apply to this method of sterilization and by providing recommendations on the proper use of table-top dry heat sterilization processing equipment. This recommended practice also covers facility design considerations, personnel considerations, work practices, and other variables that affect sterility assurance. This standard is an identical adoption of ANSI/AAMI ST40:2004/R2010, Table-top dry heat (heated air) sterilization and sterility assurance in health care facilities.
This standard applies to steam sterilizers that are intended for use in health care facilities and that have a volume less than or equal to 56.63 liters (2 cubic feet [ft3]).
NOTE—For purposes of this standard, health care facilities refers to hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term hospital is sometimes used in this standard; in all instances, this term should be taken to encompass all other health care facilities. This standard is an identical adoption of ANSI/AAMI ST55:2010, Table-top steam sterilizers.
This standard sets forth criteria related to the general requirements, testing, permanent marking(s), selection, care and use of protectors to minimize or prevent exposure to the wearer's eyes and/or face (mucocutaneous exposures, nose and mouth) caused by spray or spurt of blood, body fluids and/or other potentially infectious materials (OPIM).
It is an identical adoption of ANSI/ISEA Z87.62:2021.