21 CFR 872.3661 - Optical Impression Systems for CAD/CAM.

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There is 1 rule appearing in the Federal Register for 21 CFR 872. View below or at eCFR (GPOAccess)
§ 872.3661 Optical Impression Systems for CAD/CAM.
(a) Identification. An optical impression system for computer assisted design and manufacturing (CAD/CAM) is a device used to record the topographical characteristics of teeth, dental impressions, or stone models by analog or digital methods for use in the computer-assisted design and manufacturing of dental restorative prosthetic devices. Such systems may consist of a camera, scanner, or equivalent type of sensor and a computer with software.
(b) Classification. Class II (Special Controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of the chapter subject to the limitations in § 872.9. The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations; Guidance for Industry and FDA.” For the availability of this guidance document, see § 872.1(e).
[68 FR 19738, 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.

  • 2014-06-18; 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