21 CFR § 872.3450 - Ethylene oxide homopolymer and/or karaya denture adhesive.

---
identifier: "/us/cfr/t21/s872.3450"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.3450 - Ethylene oxide homopolymer and/or karaya denture adhesive."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.3450"
section_name: "Ethylene oxide homopolymer and/or karaya denture adhesive."
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"
---


# 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.

(a) *Identification.* Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.

(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 of this chapter subject to § 872.9.

[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 65 FR 2315, Jan. 14, 2000]