# K140349: Starbright 5% Sodium Fluoride Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Nanova Biomaterials, Inc.
- Decided: Sep 22, 2014 after 215 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: 7 generations back to K010957 (2001). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961893: Duraflor, Pharmascience, Inc. (1996) Summary page 4.
- K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish, 3M Espe Dental Products (2010) Summary page 4.
- K103160: Nupro Model 13016901, CAO Group, Inc. (2011) Summary page 4.
- K132109: Enamelast, Ultradent Products Inc. / Oratech, LLC (2013) Summary page 4.

## Indications for use
StarBrightTM 5% Sodium Fluoride Varnish is a fluoride containing preparation for use as a cavity varnish and for the treatment of dentin hypersensitivity.

Source page: https://510kreport.com/device/K140349
Methodology: https://510kreport.com/methodology