# K030663: Tokuyama Sofreliner Tough

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: May 29, 2003 after 87 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 K953589 (1996). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.
- K953589: Tokuyama Soft Relining, Tokuyama America, Inc. (1996) Summary page 1.
- K990736: GC Reline Soft/Extra Soft, GC America, Inc. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K940566: Clea Soft. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K112445: Sofreliner Tough S (2011), 0 descendants of its own

## Indications for use
For use as a denture reliner

Source page: https://510kreport.com/device/K030663
Methodology: https://510kreport.com/methodology