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New ADA standards, technical reports available for comment

October 18, 2019

The ADA Standards Committee on Dental Products has approved the following standards for circulation and comment:

  • Proposed revision of ADA Standard No. 41 for Evaluation of Biocompatibility of Medical Devices Used in Dentistry: This standard concerns the evaluation of the biocompatibility of medical devices used in dentistry. It contains special tests that acknowledge the special needs of dentistry and are supported by sufficient published data. In recommending test methods, the committee prioritized the need to minimize the number and exposure of test animals.
  • Proposed revision of ADA Standard No. 63 for Endodontic Instruments – Auxiliary: This standard specifies requirements and test methods for hand-held or mechanically operated instruments for performing root canal procedures. It specifies requirements for size, marking, product designation, safety considerations and labeling and packaging.
  • Proposed revision of ADA Standard No. 95 for Endodontic Instruments – Enlargers: This standard specifies requirements for enlargers including size, marking, product designation, safety considerations, labeling and packaging, and instructions for use.
  • Proposed ADA Technical Report No. 133 for Guide to Dental Lasers and Related Light-Based Technologies: Technology, Science and Safety Considerations: Although the use of lasers in dentistry has been considered an emerging technology, use of lasers in health care first received U.S. Food and Drug Administration approval in the early 1980s. This technical report will focus on the hard and soft tissue applications in dentistry and the recommended wavelengths to be used. The report will provide extensive scientific information on the use of lasers in dentistry with the purpose of facilitating the selection of the appropriate equipment. Additionally, the report will provide an understanding of potential hazards and safety considerations when lasers are used in the dental environment.
  • Proposed ADA Technical Report No. 168 for Guidance on Method Development and Validation of Cleaning Processes for Dental Instruments: The FDA's guidance on reprocessing medical devices in health care settings notes that "adequate sterilization or disinfection depends on the thoroughness of cleaning," "instructions to the user should clearly communicate how to achieve thorough cleaning" and "labeling should provide a detailed, validated method of cleaning." This new technical report provides guidance on the development and validation of cleaning processes for dental instruments as part of the multi-step procedure of reprocessing. Validated cleaning processes are important in achieving consistently clean and biocompatible instruments, thereby eliminating the risk of cross-contamination.

The ADA Standards Committee on Dental Informatics has approved the following standard for circulation and comment:

  • Proposed ADA Standard No. 1097 for Digital Caries Risk Assessment Resources: Caries risk assessment is an important consideration in the evidence-based management of dental caries in both children and adults and essential to the development of clinical guidelines and advancement of dental quality initiatives. There is considerable variation among both analog and digital caries risk assessment tools currently used in the U.S. in terms of input data, scoring methodologies and reporting formats. This limits the ability to compare population caries risk data to validate the effectiveness of preventive recommendations and develop quality measures for caries prevention. This new standard will provide a common platform for all stakeholders to measure individual and population risk factors for dental caries to improve the quality of clinical care.

The ADA is accredited by the American National Standards Institute to develop national standards for products and information technology used by the dental profession and consumers. Currently there are more than 90 national standards, and more are under development.

The draft standards and technical reports are available by calling the ADA at 1-312-440-2506 or emailing standards@ada.org.