21 CFR 872.3600 - Partially fabricated denture kit.

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There is 1 rule appearing in the Federal Register for 21 CFR 872. View below or at eCFR (GPOAccess)
§ 872.3600 Partially fabricated denture kit.
(a) Identification. A partially fabricated denture kit is a device composed of connected preformed teeth that is intended for use in construction of a denture. A denture base is constructed using the patient's mouth as a mold, by partially polymerizing the resin denture base materials while the materials are in contact with the oral tissues. After the denture base is constructed, the connected preformed teeth are chemically bonded to the base.
(b) Classification. Class II. The special controls for this device are FDA's:
(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000]

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