21 CFR 872.3070 - Dental amalgam, mercury, and amalgam alloy.

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There is 1 rule appearing in the Federal Register for 21 CFR 872. View below or at eCFR (GPOAccess)
§ 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-06-18; vol. 79 # 117 - Wednesday, June 18, 2014
    1. 79 FR 34623 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 18, 2014.
      21 CFR Part 872

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 872 after this date.

  • 2014-06-18; vol. 79 # 117 - Wednesday, June 18, 2014
    1. 79 FR 34623 - Dental Devices; Reclassification of Blade-Form Endosseous Dental Implant
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective July 18, 2014.
      21 CFR Part 872