(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 OTC denture repair kit is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to §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 65 FR 17144, Mar. 31, 2000; 83 FR 11145, Mar. 14, 2018]