# K090519: Vanish Varnish, 5% Sodium Fluoride Varnish, Model 12245, Vanish Varnish, 5% Fluoride Varnish, Model 12247

- Pathway: 510(k) (Special)
- Applicant: 3M Company
- Decided: Apr 15, 2009 after 48 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: 4 generations back to K010957 (2001). 7 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 11 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.
- K802926: Sci-Pharm Universal Cavity Varnish, Scientific Pharmaceuticals, Inc. (1980) Summary page 1.
- K082198: Durashield Plus, Dentsply Intl., Inc. (2008) Summary page 1.

## Most influential descendants
- K100540: Ascent F-Coat Model: 006-00097 (2010), 2 descendants of its own
- K103160: Nupro Model 13016901 (2011), 1 descendant of its own
- K140349: Starbright 5% Sodium Fluoride Varnish (2014), 0 descendants of its own

## Indications for use
Treatment of hypersensitive teeth use on exposed dentin and root sensitivity under temporary restoratives and cements where post-operative sensitivity is of concern.

Source page: https://510kreport.com/device/K090519
Methodology: https://510kreport.com/methodology