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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dental amalgam
Regulation Description Dental amalgam, mercury, and amalgam alloy.
Definition Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
Product CodeOIV
Regulation Number 872.3070
Device Class 2