§872.3570. OTC denture repair kit.
21 C.F.R. § 872.3570
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.
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:
“Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and
“OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
Notes, amendments, and revision history
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 83 FR 11145, Mar. 14, 2018]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.
Amendments
[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 17144, Mar. 31, 2000; 83 FR 11145, Mar. 14, 2018]