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Federal Register: Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalga...

Fri, 06/11/2010 - 6:35am
U.S. Food & Drug Administration

[Federal Register: June 11, 2010 (Volume 75, Number 112)]

[Rules and Regulations]

[Page 33169-33170]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr11jn10-7]

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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)

RIN 0910-AG21

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.

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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

agency's regulations.

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-

796-6276.

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

amalgam alloy.''

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

Management and

Page 33170

Budget under the Paperwork Reduction Act of 1995 is not required.

For the effective date of this final rule, see the DATES section of

this document.

List of Subjects in 21 CFR Part 872

Medical devices.

0

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

0

1. The authority citation for 21 CFR part 872 continues to read as

follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

Sec. 872.3700 [Removed]

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2. Remove Sec. 872.3700.

Dated: June 8, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.

[FR Doc. 2010-14083 Filed 6-10-10; 8:45 am]

BILLING CODE 4160-01-S

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