21 CFR 872.3570 - OTC denture repair kit.

§ 872.3570 OTC denture repair kit.

(a)Identification. An OTC denture repair kit is a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks. The device may be available for purchase over-the counter.

(b)Classification. Class II. The OTC denture repair kit is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 872.9. The special controls for this device are FDA's:

(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices - Part I: Evaluation and Testing,’ ” and

(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

[ 52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 83 FR 11145, Mar. 14, 2018]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

Title 21 published on 19-May-2018 03:57

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 872 after this date.

  • 2018-03-14; vol. 83 # 50 - Wednesday, March 14, 2018
    1. 83 FR 11144 - Medical Devices; Exemption From Premarket Notification; Class II Devices; Over-the-Counter Denture Repair Kit
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final order.
      This order is effective March 14, 2018. The exemption was applicable on January 31, 2018.
      21 CFR Part 872