(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 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]