New dental standards developed in 2015
October 14, 2015
The ADA published the following dental standards and technical reports in 2015:
Revised ANSI/ADA standard No. 119 for manual toothbrushes:
This standard describes requirements and test methods for the physical properties of manual toothbrushes in order to promote the safety of these products for their intended use.
ANSI/ADA standard No. 151 for screening method for erosion potential of oral rinses on dental hard tissues:
This standard specifies a screening method for the erosion potential of non-fluoridated oral rinses on dental hard tissues.
ANSI/ADA standard No. 128 for hydrocolloid impression materials:
This standard specifies the requirements and tests for helping determine whether the 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 labeling and instructions for use.
ANSI/ADA standard No. 136 for products for external tooth bleaching:
Products for external tooth bleaching are used in dentistry for changing the color of natural teeth towards a lighter or whiter shade. They are applied in the oral cavity directly on the outer surfaces of teeth. This standard includes requirements and test methods for products intended for external bleaching of natural teeth by chemical means.
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 has issued a rule to establish a system to adequately identify devices through distribution. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA’s Global Unique Device Identification Database unless subject to an exception or alternative.
Dental practitioners need to have an understanding of this rule and what it will entail as it is required to go into practice, from a clinician side. This report covers the UDI Rule (78 FR 58786) and device marking regulations in 21 CFR 801.45.
ADA technical report No. 1075 for electronic orthodontic dental laboratory prescriptions:
The scope of this technical report is to present the types of data and electronic format necessary to be included on an electronic orthodontic dental laboratory prescription. The goal of this report is to address the need for electronic transmission of patient information from the orthodontic provider to the outsourced dental laboratory with the necessary security and interoperability.
To read other summaries of dental standards, visit ADA.org/dental standards and click on “Standards Committee on Dental Products” or “Standards Committee on Dental Informatics.” A link to summaries of recent standards is on the left side of those webpages. For more information, email standards@ADA.org.