# K082285: Easy Glaze

- Pathway: 510(k) (Traditional)
- Applicant: Voco GmbH
- Decided: Oct 24, 2008 after 74 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 K052462 (2005). 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)
- K052462: G-COAT, GC America, Inc. (2005) Summary page 1.

## Indications for use
EASY GLAZE is intended for the following applications: 1. Surface sealing of provisional crowns and bridges, glass ionomer cements and definitive composite restorations. 2. Sealing the adhesive interfaces between restoration and tooth structure. 3. Protecting glass ionomer cement surfaces against the effects of moisture and dehydration immediately after placement. 4. Sealing glass ionomer cement liners/build-up restorations before taking impressions

Source page: https://510kreport.com/device/K082285
Methodology: https://510kreport.com/methodology