FDA Issues Final Regulation on Dental Amalgam

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Updated June 13, 2025

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Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy - Guidance for Industry and FDA Staff

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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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FDA Expected To Rule On Mercury Dental Amalgams

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I'm so glad that I don't have mercury fillings in my mouth anymore. Unfortunately, I've got a mouthful of crowns, and precious little left of my natural teeth. I ran across this press release, and thought you'd be happy to know that the FDA is expected to rule on mercury-containing dental amalgams, "Resolution to Study Phase Out of Mercury Tooth Dental Fillings Receives 16% of Vote at Danaher Shareholder Meeting." The press release states, "Some-time in late July, the Food and Drug Administration is expected to rule on the use of mercury amalgam. The Consumers for Dental Choice won a 10-year battle with the FDA to comply with the law and set a date to classify mercury amalgam." 

Related Posts: Caution - Teeth Whiteners Can Reduce Enamel Strength Mercury-Containing Dental Fillings - Health and Environmental Concerns 

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Mercury-Containing Dental Fillings - Health and Environmental Concerns

Updated June 26, 2024

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Dental Amalgam Fillings - FDA.gov

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Dental amalgam. You might also know these as mercury containing dental fillings. I've got them, you've got them, we've all got them. Yesterday there was a bit of a brouhaha over them in a hearing in Washington DC, Dental Industry Gets An Earful On Mercury. The hearing considered whether dentists should be required to keep pieces of fillings from getting into public wastewater, using special equipment. In any event, the hearing created opportunities for legislators to attack the dental industry on the purported health risks of having mercury-containing fillings in your mouth, and the ramifications of mercury getting into wastewater. If you're interested in the health risk aspect of this, I recommend this page on the FDA's website, Questions and Answers on Dental Amalgam. On a personal closing note, I rotted my teeth on childhood candy, resulting in amalgams in all my teeth; thankfully now, I have a mouthful of caps and crowns, and only one remaining amalgam.

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