# K052462: G-COAT

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 20, 2005 after 42 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
No predicates in its family tree.
6 later devices descend from it; 2 cite it directly.
0 of 7 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
- K133836: Optiglaze Color (2014), 4 descendants of its own
- K254091: Glossy Coat (15ML) (2026), 0 descendants of its own
- K250804: ID Light Cure System (2025), 0 descendants of its own
- K240735: visio.lign color, visio.lign shield (2024), 0 descendants of its own
- K153325: Gradia Plus (2016), 0 descendants of its own

## Indications for use
To seal the surface of direct composite and glass-ionomer restorations, indirect composite restorations, provisional restorations and their adhesive interface of margin to enamel or dentin.

Source page: https://510kreport.com/device/K052462
Methodology: https://510kreport.com/methodology