# K101420: GC Fuji Temp

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Sep 17, 2010 after 120 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 K842994 (1984). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980695: FUJI I, GC America, Inc. (1998) Summary page 1.
- K842994: Ema Freegenol Dental Cement, Int'L Corp. (1984) Summary page 1.

## Indications for use
Temporary cementation of crowns and bridges on implant abutments Provisional cementation of crowns and bridges

Source page: https://510kreport.com/device/K101420
Methodology: https://510kreport.com/methodology