# K133836: Optiglaze Color

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Mar 6, 2014 after 78 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.
4 later devices descend from it; 4 cite it directly.
0 of 6 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.

## Most influential descendants
- 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
1. For characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth. 2. For obtaining surface smoothness and wear resistance of restorations made of composite-resin, acrylic denture base and artificial acrylic teeth.

Source page: https://510kreport.com/device/K133836
Methodology: https://510kreport.com/methodology