# K112445: Sofreliner Tough S

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Oct 28, 2011 after 65 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: 2 generations back to K953589 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982537: Tokuyama Sofreliner, Tokuyama America, Inc. (1998) Summary page 2.
- K030663: Tokuyama Sofreliner Tough, Tokuyama Dental Corporation (2003) Summary page 2.
- K990736: GC Reline Soft/Extra Soft, GC America, Inc. (1999) Summary page 2.

## Indications for use
The SOFRELINER. TOUGH S denture relining, repairing, or rebasing resin device is for use as a denture reliner.

Source page: https://510kreport.com/device/K112445
Methodology: https://510kreport.com/methodology