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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR872.3070]
See Related Information on Dental amalgam, mercury, and amalgam alloy. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 872 -- DENTAL DEVICES

Subpart D--Prosthetic Devices

Sec. 872.3070 Dental amalgam, mercury, and amalgam alloy.

(a)Identification. Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.

(b)Classification. Class II (special controls). The special control for this device is FDA's "Class II Special Controls Guidance Document: Dental Amalgam, Mercury, and Amalgam Alloy."See 872.1(e) for the availability of this guidance document.

[74 FR 38714, Aug. 4, 2009]

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