# K151302: Clinpro Varnish

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 18, 2015 after 126 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: 3 generations back to K051750 (2005). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish, 3M Espe Dental Products (2010) Summary page 4.
- K093620: Pulpdent Fluoride Varnish, Pulpdent Corporation (2010) Summary page 4.
- K112946: Activ Varnish, Pulpdent Corporation (2011) Summary page 4.
- K945794: Duraphat, Inpharma (1995) Summary page 4.

## Indications for use
Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in: Treating hypersensitive teeth Treating exposed dentin and root sensitivity

Source page: https://510kreport.com/device/K151302
Methodology: https://510kreport.com/methodology