---
kind: "section"
citation: "21 C.F.R. § 872.3540"
title: "21"
number: "872.3540"
heading: "OTC denture cushion or pad."
url: "https://uscodex.org/cfr/21/872.3540"
---

# §872.3540. OTC denture cushion or pad.

- (a) **Identification.** An OTC denture cushion or pad is a prefabricated or noncustom made disposable device that is intended to improve the fit of a loose or uncomfortable denture, and may be available for purchase over-the-counter.
- (b) **Classification.**
  - (1) Class I if the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the 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).
  - (2) Class II (special controls) if the OTC denture cushion or pad is made of a material other than wax-impregnated cotton cloth or if the intended use of the device differs from that described in [paragraph (b)(1)](#b-1) of this section. The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 872.9](/cfr/21/872.9.md). The special controls for this device are FDA's:
    - (i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical—Devices Part I: Evaluation and Testing,’ ” and
    - (ii) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”

## Notes

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 65 FR 2315, 2000; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]

### 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 2315, 2000; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]