21 CFR § 872.3260 - Cavity varnish.
---
identifier: "/us/cfr/t21/s872.3260"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 872.3260 - Cavity varnish."
title_number: 21
title_name: "Food and Drugs"
section_number: "872.3260"
section_name: "Cavity varnish."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "872"
part_name: "DENTAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 30097, Aug. 12, 1987, unless otherwise noted."
cfr_part: "872"
---
# 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]