---
kind: "section"
citation: "21 C.F.R. § 872.3570"
title: "21"
number: "872.3570"
heading: "OTC denture repair kit."
url: "https://uscodex.org/cfr/21/872.3570"
---

# §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 OTC denture repair kit is exempt from premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter, subject to [§ 872.9](/cfr/21/872.9.md). 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.”

## Notes

### 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]