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About This Item


Full Description

This standard covers standard practices for the biological evaluation of the safety of medical devices used in dentistry. In addition, this document covers biological evaluation of the device component of combination products, including those with a pharmacological agent or biologic component as an integral part of the device.

This standard does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body.

Document History

  1. ADA 41-2015


    Evaluation of Biocompatibility of Medical Devices Used in Dentistry

    • Most Recent
  2. ADA 41-2005

    Biological Evaluation of Dental Materials & 41a, Addendum

    • Historical Version