# K163568: Shofu Resin Glaze

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corporation
- Decided: Aug 16, 2017 after 240 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
SHOFU RESIN GLAZE is indicated to temporarily glaze the following restoration surfaces: * Artificial resin teeth * Acrylic denture base materials * CAD/CAM PMMA materials * CAD/CAM hybrid ceramic materials * Indirect composite resins * Provisional materials

Source page: https://510kreport.com/device/K163568
Methodology: https://510kreport.com/methodology