21 C.F.R. § 872.3260 Cavity varnish.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§ 872.3260 Cavity varnish.

