# K090597: Fluorilaq Sodium Fluoride Cavity Varnish

- Pathway: 510(k) (Special)
- Applicant: Pascal Co., Inc.
- Decided: Mar 16, 2009 after 11 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)
- K030488: Fluorilaq, Pascal Co., Inc. (2003) Summary page 1.

## Indications for use
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.

Source page: https://510kreport.com/device/K090597
Methodology: https://510kreport.com/methodology