# K190940: Tokuyama Rebase III

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Oct 4, 2019 after 177 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 K982695 (1998). 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)
- K982695: GC Reline, GC America, Inc. (1998) Summary page 6.

## Indications for use
The TOKUYAMA REBASE III device is for relining dentures and extension of denture borders.

Source page: https://510kreport.com/device/K190940
Methodology: https://510kreport.com/methodology