21 CFR 872.3260
§ 872.3260 Cavity varnish.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 872.3260, § 872.3260 Cavity varnish, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90073
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Full text
(a) Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.
(b) Classification. Class II (special controls). The device, when it is an external cleaning solution, 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.