# K984365: GC Unifast Trad

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: Feb 25, 1999 after 80 days
- Product code: EBI (Resin, Denture, Relining, Repairing, Rebasing)
- Device class: 2
- Regulation: 21 CFR 872.3760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K170549: Tokuyama Curegrace (2017), 0 descendants of its own

## Indications for use
GC Unifast Trad is an acrylic resin used in a variety of dental applications such as repair of full or partial acrylic dentures. Construction of temporary crowns. Impression trays for individual teeth. Check bit registration. Construction and repair of orthodontic plates and splints.

Source page: https://510kreport.com/device/K984365
Methodology: https://510kreport.com/methodology