# K162408: Nano Varnish, Plaquit, Lightpaint on Surface

- Pathway: 510(k) (Traditional)
- Applicant: Dreve Dentamid GmbH
- Decided: Apr 5, 2018 after 584 days
- Product code: EBD (Coating, Filling Material, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3310
- 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 K123761 (2013). 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)
- K123761: Vita Enamic Stains, Innovation Meditech GmbH (2013) Summary page 4.

## Indications for use
Varnish for final coating for resin temporaries to produce a smooth and shiny surface.

Source page: https://510kreport.com/device/K162408
Methodology: https://510kreport.com/methodology