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2009-08-04
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Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy
Part II
Rules and Regulations
D09002ee1bdd3077e
D09002ee1bdd30832
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, ``Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the devices.
74 FR 38686
https://www.govinfo.gov/app/details/FR-2009-08-04/E9-18447
E9-18447
FR04AU09-15
RIN 0910-AG21
P
Docket No. FDA-2008-N-0163
Formerly Docket No. 2001N-0067
https://www.govinfo.gov/app/details/FR-2009-08-04/E9-18447
https://www.govinfo.gov/content/pkg/FR-2009-08-04/html/E9-18447.htm
https://www.govinfo.gov/content/pkg/FR-2009-08-04/pdf/E9-18447.pdf
Medical Devices
29 p.
38686
38714
74 FR 38686
Code of Federal Regulations
Title 21 Part 872
21 CFR Part 872
Regulation Identification Number 0910-AG21
RIN 0910-AG21
Dental Devices: Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy; Federal Register Vol. 74, Issue
RULE
E9-18447
II
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2009-11-02
Docket No. FDA-2008-N-0163
Formerly Docket No. 2001N-0067
P
E9-18447
Final rule.
The Food and Drug Administration (FDA) is issuing a final rule classifying dental amalgam into class II, reclassifying dental mercury from class I to class II, and designating a special control to support the class II classifications of these two devices, as well as the current class II classification of amalgam alloy. The three devices are now classified in a single regulation. The special control for the devices is a guidance document entitled, ``Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy.'' This action is being taken to establish sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of these devices. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document that will serve as the special control for the devices.
This rule is effective November 2, 2009.
Michael E. 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.
Medical Devices
Dental Devices:
Classification of Dental Amalgam, Reclassification of Dental Mercury, Designation of Special Controls for Dental Amalgam, Mercury, and Amalgam Alloy
,
http://emedicine.medscape.com/article/819872-overview
http://www.atsdr.cdc.gov/mrls/
http://www.epa.gov/ncea/iris/help_gloss.htm#r
http://www.epa.gov/osa/pdfs/ratf-final.pdf
Federal Register
Vol. 74, no. 148
Office of the Federal Register, National Archives and Records Administration
2009-08-04
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deposited
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391 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2009-08-04
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https://www.govinfo.gov/app/details/FR-2009-08-04
https://www.govinfo.gov/content/pkg/FR-2009-08-04/pdf/FR-2009-08-04.pdf
https://www.govinfo.gov/content/pkg/FR-2009-08-04/xml/FR-2009-08-04.xml
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2009-08-04
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