21 CFR 872.3300
§ 872.3300 Hydrophilic resin coating for dentures.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.3300, § 872.3300 Hydrophilic resin coating for dentures, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90076
- Permanent ID
ys:prov:90076@1- SHA-256
72533965590cf31127b8fbee70570c0dd36af6431d7cb0d29b24a1fe1dfe79e9
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Full text
(a) Identification. A hydrophilic resin coating for dentures is a device that consists of a water-retaining polymer that is intended to be applied to the base of a denture before the denture is inserted into the patient's mouth to improve denture retention and comfort.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.