Dental devices: classification of dental amalgam, reclassification of dental mercury, designation of special controls for dental amalgam, mercury, and amalgam alloy; technical amendment. Final rule; technical amendment.
The Food and Drug Administration (FDA) published a final rule in the Federal Register of August 4, 2009 (74 FR 38686) which classified dental amalgam as a class II device, reclassified dental mercury from class I to class II, and designated special controls for dental amalgam, mercury, and amalgam alloy. The effective date of the rule was November 2, 2009. The final rule was published with an inadvertent error in the codified section. This document corrects that error. This action is being taken to ensure the accuracy of the agency's regulations.
D003722:Dental Alloys / Q000145:classification*; D003723:Dental Amalgam / Q000145:classification*; D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D008628:Mercury / Q000145:classification*; D017669:Mercury Compounds / Q000145:classification; D014481:United States
D003722:Dental Alloys; D017669:Mercury Compounds; D003723:Dental Amalgam; D008628:Mercury