# K050401: Ceramage

- Pathway: 510(k) (Traditional)
- Applicant: Shofu Dental Corp.
- Decided: Apr 28, 2005 after 70 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K143694: Rhondium One-Visit-Crown (OVC) (2015), 2 descendants of its own
- K172952: Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit (2018), 0 descendants of its own
- K162677: L- OVC (2016), 0 descendants of its own

## Indications for use
Ceramage is light-curing polymer based crown and bridge, inlay, onlay composite resin materials for anterior and posterior. CERAMAGE is intended for use for following: * Used for crown restorations, e.g. jacket crowns and facing crowns for anterior and posterior, inlays, onlays, laminate veneers and upper structure prosthetic of implants. * Used for extra/intra-oral repair of crown restorations and defect restorations.

Source page: https://510kreport.com/device/K050401
Methodology: https://510kreport.com/methodology