Federal Register: Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalga...
[Federal Register: June 11, 2010 (Volume 75, Number 112)]
[Rules and Regulations]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 872
[Docket No. FDA-2008-N-0163] (formerly Docket No. 2001N-0067)
Dental Devices: Classification of Dental Amalgam,
Reclassification of Dental Mercury, Designation of Special Controls for
Dental Amalgam, Mercury, and Amalgam Alloy; Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
SUMMARY: 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
DATES: This rule is effective June 11, 2010.
FOR FURTHER INFORMATION CONTACT: Michael Adjodha, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 2606, Silver Spring, MD 20993-0002, 301-
SUPPLEMENTARY INFORMATION: Dental amalgam is a metallic restorative
material that is used for the direct filling of carious lesions or
structural defects in teeth. Dental amalgam is a combination of
elemental mercury (liquid) and amalgam alloy (powder), which is
composed primarily of silver, tin, and copper (74 FR 38686). The final
rule classified the device ``dental amalgam'' into class II;
reclassified the device ``dental mercury'' (hereinafter ``mercury'')
from class I to class II; and designated a special controls guidance
document to support the class II classifications of dental amalgam,
mercury, and the device ``amalgam alloy.'' The final rule classified
all three devices together in a single regulation, by establishing a
new section 21 CFR 872.3070, entitled ``Dental amalgam, mercury, and
With the establishment of a single classification regulation for
the three devices, supported by a designated class II special controls
guidance document, FDA also intended to remove from codification the
previous classifications of dental mercury and amalgam alloy as
separate devices under 21 CFR 872.3700 and 21 CFR 872.3050,
respectively. FDA removed the previous classification of amalgam alloy
in the codified section of the final rule (74 FR 38686 at 38714), but
inadvertently did not remove the previous classification of dental
mercury. This document corrects that error.
Publication of this document constitutes final action on the change
under the Administrative Procedure Act (5 U.S.C. 553). This technical
amendment merely removes a regulatory reference in the Code of Federal
Regulations (CFR) that was inadvertently not removed in the final rule.
FDA therefore, for good cause, has determined that notice and public
comment are unnecessary, under 5 U.S.C. 553(b)(3)(B). Further, this
rule places no burden on affected parties for which such parties would
need a reasonable time to prepare for the effective date of the rule.
Accordingly, FDA, for good cause, has determined this technical
amendment to be exempt under 5 U.S.C. 553(d)(3) from the 30-day
effective date from publication.
FDA has determined under 21 CFR 25.30(i) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required. In
addition, FDA has determined that this final rule contains no
collections of information. Therefore, clearance by the Office
Budget under the Paperwork Reduction Act of 1995 is not required.
For the effective date of this final rule, see the DATES section of
List of Subjects in 21 CFR Part 872
Therefore, under the Federal Food, Drug, and Cosmetic Act, and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
872 is amended as follows:
PART 872--DENTAL DEVICES
1. The authority citation for 21 CFR part 872 continues to read as
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
Sec. 872.3700 [Removed]
2. Remove Sec. 872.3700.
Dated: June 8, 2010.
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14083 Filed 6-10-10; 8:45 am]
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