Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Technical Amendment
Information
Type
Rule
Regulated products
Published
June 11, 2010
Last updated
June 11, 2010
Description
Document number 2010-14083. 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.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)