# K980682: Fuji II

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Apr 3, 1998 after 39 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
- K101869: Proglass Cements (One, Two Two LC, Nine, Plus, Silver) (2010), 3 descendants of its own
- K210473: Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) (2021), 0 descendants of its own
- K200555: Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) (2021), 0 descendants of its own
- K160345: Glass Ionomer Cement (2017), 0 descendants of its own
- K123824: Vitro Fil LC (2013), 0 descendants of its own

## Indications for use
Fuji I is a self-cure glass ionomer material intended for the use as a dental restorative for the following typical applications: Restoration of primary teeth. Core build-ups. Class Ill, V and limited Class | cavities.

Source page: https://510kreport.com/device/K980682
Methodology: https://510kreport.com/methodology