21 C.F.R. § 872.3560 OTC denture reliner.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§ 872.3560 OTC denture reliner.
