OTC denture reliner.

§ 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 (special 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. 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; 84 FR 71812, Dec. 30, 2019]