FDA Classifies Amalgam, Recommends Labeling

The FDA has classified dental amalgam as Class II, special controls, and is recommending that it carry a warning that it should not be used on patients who are allergic to mercury. The special controls the FDA is imposing on dental amalgam are outlined in a guidance issued last week to support its classification, the reclassification of dental mercury from Class I to Class II and the classification of amalgam alloy as Class II. The three devices are now classified in a single regulation, according to the guidance, which replaces a 2002 draft version.
Devices & Diagnostics Letter