# K102808: MI Varnish

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Dec 22, 2010 after 85 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 K961893 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K092141: Vanish Varnish, 5% Sodium Fluoride White Varnish, 3M Espe Dental Products (2010) Summary page 1.

## Indications for use
MI Varnish is a fluoride varnish with RecaldentTM (CPP-ACP) that has a desensitizing action when applied to tooth surfaces. The application leaves a film of varnish on tooth and this may allow visual control and verification.

Source page: https://510kreport.com/device/K102808
Methodology: https://510kreport.com/methodology