21 CFR 872.1 - Scope.

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§ 872.1 Scope.
(a) This part sets forth the classification of dental devices intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by § 807.87.
(c) To avoid duplicative listings, a dental device that has two or more types of uses (e.g., used both as a diagnostic device and as a therapeutic device) is listed in one subpart only.
(d) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
(e) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/cdrh.guidance.html.
[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19737, Apr. 22, 2003]

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.

  • 2014-08-25; vol. 79 # 164 - Monday, August 25, 2014
    1. 79 FR 50551 - Medical Devices; Technical Amendment
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective August 25, 2014.
      21 CFR Parts 862, 864, 866, and 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.

  • 2014-09-18; vol. 79 # 181 - Thursday, September 18, 2014
    1. 79 FR 56027 - Dental Devices; Reclassification of Salivary Stimulatory System, To Be Renamed Electrical Salivary Stimulator System
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed Order.
      Submit either electronic or written comments by December 17, 2014. Please see section IX of this document for the proposed effective date of any final order that may publish based on this proposed order.
      21 CFR Part 872