FDA Issues Final Regulation on Dental Amalgam

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Updated April 21, 2017

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I'm pleased to say that after having a mouthful of these things, I'm now down to just one amalgam. OK, so the rest of my teeth are crowns, oh well. This FDA News Release, FDA Issues Final Regulation on Dental Amalgam, reports:

• The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
• The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.

To learn more about dental amalgams from the FDA, go to: Dental Amalgam
Previous Posts:
FDA Expected To Rule On Mercury Dental Amalgams
Mercury-Containing Dental Fillings - Health and Environmental Concerns


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