Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Technical Amendment
other · Food and Drug Administration · Rule · Published 2010-06-11 · Effective 2010-06-11 · 75 FR 33169
Document
Document number
2010-14083
Federal Register citation
75 FR 33169
CFR reference
21 CFR 872
Type
Rule
Action
Final rule; technical amendment.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2010-06-11
Effective date
2010-06-11
HHS docket
Docket No. FDA-2008-N-0163
Abstract
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.