# K062683: Enamel Pro Varnish

- Pathway: 510(k) (Traditional)
- Applicant: Premier Dental Products Co.
- Decided: Nov 21, 2006 after 74 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K160377: V-varnish Premium (2016), 0 descendants of its own

## Indications for use
Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.

Source page: https://510kreport.com/device/K062683
Methodology: https://510kreport.com/methodology