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e-CFR data is current as of February 23, 2021

Title 21Chapter ISubchapter HPart 872Subpart D → §872.3260


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices


§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]

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