Standards related to oral rinses, pit and fissure sealants, others up for comment
July 18, 2018
Dental professionals interested in helping develop standards related to informatics, digital technologies, or products and materials for dentistry are invited to review and comment on the following ADA-developed standards and technical reports.
The draft standards and technical reports are available by calling the ADA toll-free number, ext. 2506, or sending an e-mail request to firstname.lastname@example.org.
The ADA Standards Committee on Dental Products has approved for circulation and comment the following standards:
- Proposed Revision of ANSI/ADA Standard No. 39 for Pit and Fissure Sealants: The efficacy of pit and fissure sealants for the prevention of dental caries is widely accepted, which has created a need for this standard. It covers requirements and test methods for polymer-based materials intended for this purpose.
- Proposed Revision of ANSI/ADA Standard No. 116 for Oral Rinses: Oral rinses are used for oral hygiene purposes intended to provide health and/or cosmetic benefits. This standard specifies the chemical and physical properties of oral rinses in order to help guarantee their safety in use.
- Proposed Revision of ANSI/ADA Standard No. 96 for Dental Water-based Cements: This standard 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 and 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 2 outlines the requirements and test methods for cements in which setting is achieved by a combination of an acid-base reaction and polymerization.
- Proposed ANSI/ADA Standard No. 157 for Powered Dental Scaler Handpieces and Tips: Powered scaler handpieces and tips have grown in usage over the years and new technical developments have resulted in improved devices, creating a need for this new standard to help ensure optimum safety and performance. The standard provides test methods and requirements for air-powered and electrical-powered scaler handpieces and scaler tips for use in patient treatment.
The ADA Standards Committee on Dental Informatics has approved for circulation and comment the following technical reports:
- Proposed Revision of ADA Technical Report No. 1081 for FDA's Unique Device Identification Program for Dental Devices and Biologics Regulated as Medical Devices: The Food and Drug Administration's rule requiring that labels of medical devices include a unique device identifier identifies the manufacturer's chain of responsibilities, but does not address clinical usage in dental practices, which is the subject of this technical report. Practitioners need to have an understanding of the rule, the dental devices that are covered, what is required of a dental practice and how the program can benefit a practice. The revision of ADA Technical Report No. 1081 updates the schedule of reporting and deadlines for the different compliance device classes.
- Proposed ADA Technical Report No. 1084 for Reference Core Data Set for Communication among Dental and other Health Information Systems: The Reference Core Data Set provides a technical specification to format and transmit essential electronic patients' demographic and dental and medical encounter and clinical data between one dental information system to another dental or medical health information system. This provides interoperability of essential patients' data in a structured, computable format for sharing between dental or other health care venues.