21 CFR 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 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.”