# K132109: Enamelast

- Pathway: 510(k) (Traditional)
- Applicant: Ultradent Products Inc. / Oratech, LLC
- Decided: Nov 1, 2013 after 116 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K051750 (2005). 2 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080249: Flor-Opal Varnish White; Models 4503, 4504, 4506, S4505, Ultradent Products, Inc. (2008) Summary page 2.

## Most influential descendants
- 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
- K141422: Profluoro Fluoride Varnish (2014), 0 descendants of its own
- K140349: Starbright 5% Sodium Fluoride Varnish (2014), 0 descendants of its own

## Recalls of this device
- Jul 12, 2018 · Class II · Z-0690-2019: Dental varnish has the possibility of having an unpleasant and off flavor.
- Jul 6, 2018 · Class II · Z-0368-2019: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

## Indications for use
Enamelast TM Fluoride Varnish is 5%sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Source page: https://510kreport.com/device/K132109
Methodology: https://510kreport.com/methodology