# K170549: Tokuyama Curegrace

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Jul 5, 2017 after 131 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
Longest line of descent: 1 generation back to K984365 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984365: GC Unifast Trad, GC America, Inc. (1999) Summary page 7.

## Indications for use
The TOKUYAMA CUREGRACE device is an acrylic resin used in a variety of dental applications such as: - Temporary inlay, crowns and bridges - Repair of broken or cracked dentures - Denture border extension. - Replacement of lost denture teeth - Adjustment of the occlusal height of resin teeth

Source page: https://510kreport.com/device/K170549
Methodology: https://510kreport.com/methodology