# K030488: Fluorilaq

- Pathway: 510(k) (Traditional)
- Applicant: Pascal Co., Inc.
- Decided: May 2, 2003 after 77 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). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982915: Sci-Pharm DFV Varnish, Scientific Pharmaceuticals, Inc. (1999) Summary page 1.
- K945794: Duraphat, Inpharma (1995) Summary page 1.
- K961893: Duraflor, Pharmascience, Inc. (1996) Summary page 1.
- (no number) Varnish, cavity: named in the summary without a submission number

## Most influential descendants
- K113146: PCXX Varnish (2012), 0 descendants of its own
- K090597: Fluorilaq Sodium Fluoride Cavity Varnish (2009), 0 descendants of its own

## 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/K030488
Methodology: https://510kreport.com/methodology