21 CFR 872.3730 - Pantograph.

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There are 2 Updates appearing in the Federal Register for 21 CFR 872. View below or at eCFR (GPOAccess)
§ 872.3730 Pantograph.
(a) Identification. A pantograph is a device intended to be attached to a patient's head to duplicate lower jaw movements to aid in construction of restorative and prosthetic dental devices. A marking pen is attached to the lower jaw component of the device and, as the patient's mouth opens, the pen records on graph paper the angle between the upper and the lower jaw.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[52 FR 30097, Aug. 12, 1987, as amended at 66 FR 38798, July 25, 2001]

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.

  • 2014-08-25; 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