---
kind: "section"
citation: "21 C.F.R. § 872.3260"
title: "21"
number: "872.3260"
heading: "Cavity varnish."
url: "https://uscodex.org/cfr/21/872.3260"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 872.9](/cfr/21/872.9.md).

## Notes

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 30097, Aug. 12, 1987, unless otherwise noted.

### Amendments

[52 FR 30097, Aug. 12, 1987, as amended at 84 FR 71812, Dec. 30, 2019]