# K182854: GC FujiCEM 2 (Improved)

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Jul 11, 2019 after 274 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: 1 generation back to K001730 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001730: GC Fujicem, GC America, Inc. (2000) Summary page 4.

## Most influential descendants
- K214118: Riva Cem Automix (2022), 0 descendants of its own

## Indications for use
Cementation of metal‐based inlays, onlays, crowns and bridges Cementation of resin inlays, onlays, crowns and bridges Cementation of all ceramic inlays Cementation of high strength (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges Cementation of metal, ceramic and fiber posts

Source page: https://510kreport.com/device/K182854
Methodology: https://510kreport.com/methodology