# K080814: Voco Profluorid Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Jul 24, 2008 after 122 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). 4 ancestors in all.
No later device cites it as a predicate yet.
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.
- K031932: Fluoride Varnish, Dentsply Intl. (2003) Summary page 1.
- K961893: Duraflor, Pharmascience, Inc. (1996) Summary page 1.

## Indications for use
VOCO Profluorid Varnish is intended for use as - Treatment of hypersensitive teeth, - Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces - Cavity liner under amalgam restorations

Source page: https://510kreport.com/device/K080814
Methodology: https://510kreport.com/methodology