# K984341: Sternvantage Varnish LC, Model 221001

- Pathway: 510(k) (Traditional)
- Applicant: Sterngold/Implamed
- Decided: Jan 8, 1999 after 35 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- 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 K892452 (1989). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892452: Palaseal (R), Kulzer, Inc. (1989) Summary page 1.

## Indications for use
SternVantage Varnish LC is a surface sealing and finishing material for use on polymerized composite surfaces, denture bases, and temporary crowns and bridges.

Source page: https://510kreport.com/device/K984341
Methodology: https://510kreport.com/methodology