# K172382: GC Fuji Direct

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Apr 2, 2018 after 237 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 K051427 (2005). 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)
- K051427: GC Fuji Fil LC, GC America, Inc. (2005) Summary page 4.

## Most influential descendants
- K192530: Surefil one Self-adhesive Composite Hybrid (2020), 0 descendants of its own

## Indications for use
1. Class III and V restorations 2. Restoration of primary teeth 3. Core build-up 4. Cases where radiopacity is required 5. Base material for Class I and Class II cavities using a sandwich laminate technique.

Source page: https://510kreport.com/device/K172382
Methodology: https://510kreport.com/methodology