# K080249: Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505

- Pathway: 510(k) (Special)
- Applicant: Ultradent Products, Inc.
- Decided: Feb 8, 2008 after 8 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 K051750 (2005). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051750: Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502, Ultradent Products, Inc. (2005) Summary page 1.

## Most influential descendants
- K132109: Enamelast (2013), 4 descendants of its own
- K112946: Activ Varnish (2011), 1 descendant of its own
- K253052: Fluoride Varnish (Type A,Type C) (2026), 0 descendants of its own
- K243777: Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) (2025), 0 descendants of its own
- K151302: Clinpro Varnish (2015), 0 descendants of its own

## Indications for use
Flor-Opal Varnish White is 5% sodium fluoride in a varnish carrier which produces a mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Source page: https://510kreport.com/device/K080249
Methodology: https://510kreport.com/methodology