Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy.

Author: United States Food and Drug Administration.

Source: FDA Website

Year: 2009

Comment:

This is the FDA's 2009 Final Rule on amalgam, which classifies dental mercury amalgam for the first time in Class II without requiring any significant special controls.

Abstract / Excerpt:

“SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, ‘Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.’ This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the FEDERAL REGISTER, FDA is announcing the availability of the guidance document that will serve as the special control for the devices.”

Citation:

United States Food and Drug Administration. Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy. 2009. http://www.fda.gov/downloads/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/UCM174024.pdf.