# K200798: G-Cem One

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Nov 24, 2020 after 243 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: 12 generations back to K931812 (1993). 61 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153231: G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer, GC America, Inc. (2016) Summary page 4.

## Most influential descendants
- K254109: G-Cem Universal (2026), 0 descendants of its own
- K254063: iCEM Universal Plus (2025), 0 descendants of its own
- K242366: OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment (2025), 0 descendants of its own

## 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/K200798
Methodology: https://510kreport.com/methodology