Document ID: FDA-2008-N-0163-0294
Agency: fda
Document Type: Rule
Title: Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Technical Amendment
Posted Date: 2010-06-11T04:00Z

[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