21 CFR 872.3640 - Endosseous dental implant.

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§ 872.3640 Endosseous dental implant.
(a) Identification. An endosseous dental implant is a device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
(b) Classification.
(1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
(2) Class III (premarket approval). The device is classified as class III if it is a blade-form endosseous dental implant.
[69 FR 26304, May 12, 2004]

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
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      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