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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2014]
[CITE: 21CFR872.3560]
See Related Information on OTC denture reliner. in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 872 -- DENTAL DEVICES

Subpart D--Prosthetic Devices

Sec. 872.3560 OTC denture reliner.

(a) Identification. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.

(b) Classification. Class II. 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 61 FR 50707, Sept. 27, 1996; 65 FR 17144, Mar. 31, 2000]

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