21 CFR 872.3820 - Root canal filling resin.

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There is 1 rule appearing in the Federal Register for 21 CFR 872. View below or at eCFR (GPOAccess)
§ 872.3820 Root canal filling resin.
(a) Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.
(b) Classification.
(1) Class II if chloroform is not used as an ingredient in the device.
(2) Class III if chloroform is used as an ingredient in the device.
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
[52 FR 30097, Aug. 12, 1987, as amended at 61 FR 50707, Sept. 27, 1996]

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