# K122331: Cavity Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply International, Inc.
- Decided: Oct 15, 2012 after 74 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945794 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031932: Fluoride Varnish, Dentsply Intl. (2003) Summary page 1.

## Indications for use
5% Sodium Fluoride Varnish is indicated for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparations.

Source page: https://510kreport.com/device/K122331
Methodology: https://510kreport.com/methodology