21 CFR § 872.3560 - OTC denture reliner.

---
identifier: "/us/cfr/t21/s872.3560"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.3560 - OTC denture reliner."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.3560"
section_name: "OTC denture reliner."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---


# 872.3560 OTC denture reliner.

(a) *Identification.* An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.

(b) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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 61 FR 50707, Sept. 27, 1996; 65 FR 17144, Mar. 31, 2000; 84 FR 71812, Dec. 30, 2019]