# K051750: Flor-Opal Varnish, Models UP 4500/ UP 4501/ UP 4502

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products, Inc.
- Decided: Sep 19, 2005 after 82 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
No predicates in its family tree.
8 later devices descend from it; 1 cites 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K080249: Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505 (2008), 7 descendants of its own
- 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

## 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. Product is also intended for use to seal dentinal tubules in cavity preparations or on sensitive root surfaces.

Source page: https://510kreport.com/device/K051750
Methodology: https://510kreport.com/methodology