# K254109: G-Cem Universal

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: May 18, 2026 after 150 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K931812 (1993). 62 ancestors in all.
No later device cites it as a predicate yet.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200798: G-Cem One, GC America, Inc. (2020) Summary page 5.

## Indications for use
1. Cementation of all types of all ceramic, resin, and metal-based inlays, onlays, crowns and bridges. 2. Cementation of metal, ceramic, fiber posts, and cast post and cores. 3. Cementation of all ceramic and composite veneers. 4. Final cementation of crowns and bridges on implant abutments.

Source page: https://510kreport.com/device/K254109
Methodology: https://510kreport.com/methodology