# K031932: Fluoride Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Intl.
- Decided: Sep 15, 2003 after 84 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: 1 generation back to K945794 (1995). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945794: Duraphat, Inpharma (1995) Summary page 1.
- K002581: Duragard Sodium Fluoride Varnish, Sultan Dental Products, Ltd. (2000)

## Most influential descendants
- K122331: Cavity Varnish (2012), 0 descendants of its own
- K080814: Voco Profluorid Varnish (2008), 0 descendants of its own

## Indications for use
Treatment of hypersensitive teeth Sealing of dentinal tubules for cavity preparations or on sensitive root surfaces Cavity liner

Source page: https://510kreport.com/device/K031932
Methodology: https://510kreport.com/methodology