# K953589: Tokuyama Soft Relining

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama America, Inc.
- Decided: Jan 18, 1996 after 170 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030663: Tokuyama Sofreliner Tough (2003), 1 descendant of its own
- K112445: Sofreliner Tough S (2011), 0 descendants of its own
- K983357: Mucopren Soft Relining System (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K953589
Methodology: https://510kreport.com/methodology