# K254091: Glossy Coat (15ML)

- Pathway: 510(k) (Traditional)
- Applicant: YAMAHACHI DENTAL MFG., Co.
- Decided: Apr 6, 2026 after 108 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: 2 generations back to K052462 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133836: Optiglaze Color, GC America, Inc. (2014) Summary page 5.

## Indications for use
GLOSSY COAT is indicated for use in the oral cavity or on a working model to coat the surface of resin-based dental prostheses (e.g., crowns, bridges, and dentures) in order to improve surface smoothness and wear resistance.

Source page: https://510kreport.com/device/K254091
Methodology: https://510kreport.com/methodology