The U.S. Food and Drug Administration (FDA) just issued a final regulation classifying dental amalgam, the silver colored dental fillings which contain mercury, and its component parts—elemental mercury and a powder alloy.
The regulation classifies dental amalgam into Class II—a 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 FDA explained that while elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients. (more…)

