# K013198: Fuji Vii Capsule

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Oct 29, 2001 after 34 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K073395: Gilb-2, Glass Ionomer Protective Coating (2008), 3 descendants of its own
- K091632: SPK Sealant (2009), 2 descendants of its own
- K100062: Infiltration Kit (2010), 1 descendant of its own
- K251124: G-Bond Universal (2025), 0 descendants of its own
- K193484: GC Fuji Triage EP (2020), 0 descendants of its own

## Indications for use
GC Fuji VII is a capsulated restorative glass jonomer cement intended for : Treatment of early non-cavitated lcsions; such as tooth brush abrasion and Root surface senditivity. Pit and Fissure Sealant Intermediate Trestorative material Temporary filling of endodontic access

Source page: https://510kreport.com/device/K013198
Methodology: https://510kreport.com/methodology