# K030844: Final Varnish LC

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Jun 13, 2003 after 88 days
- Product code: KLE (Agent, Tooth Bonding, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
Protection of glass ionomer cement surfaces against both humidity and dryin,g immediately after placing the filling Sealing and smoothing of glass ionomer cement surfaces after polishing Sealing of cervical margin of cementations immediately after removal of excess

Source page: https://510kreport.com/device/K030844
Methodology: https://510kreport.com/methodology