21 CFR 872.3450
§ 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.3450, § 872.3450 Ethylene oxide homopolymer and/or karaya denture adhesive, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90084
- Permanent ID
ys:prov:90084@1- SHA-256
afeac22d7a077d5a9bdfd8dcff87d69992346b5a517fa4635c23ff6122f9e3db
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.