21 C.F.R. · Food and Drugs
21 C.F.R. § 872.3260

Cavity varnish.

Title 21 C.F.R. ● ACTIVE Primary Source
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21 C.F.R. § 872.3260 — Cavity varnish.

§ 872.3260 Cavity varnish. (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. [52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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The regulatory text of 21 C.F.R. § 872.3260 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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