# K141422: Profluoro Fluoride Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Pac-Dent International, Inc.
- Decided: Sep 30, 2014 after 123 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: 3 generations back to K051750 (2005). 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)
- K132109: Enamelast, Ultradent Products Inc. / Oratech, LLC (2013) Summary page 4.

## Indications for use
ProFluoro Fluoride Varnish is intended for use as: Professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film

Source page: https://510kreport.com/device/K141422
Methodology: https://510kreport.com/methodology