# K990736: GC Reline Soft/Extra Soft

- Pathway: 510(k) (Traditional)
- Applicant: GC America, Inc.
- Decided: May 28, 1999 after 84 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; 3 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’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030663: Tokuyama Sofreliner Tough (2003), 1 descendant of its own
- K153253: GC Reline II (2016), 0 descendants of its own
- K112445: Sofreliner Tough S (2011), 0 descendants of its own

## Indications for use
GC Reline Soft / Extra Soft is a resilient material for making soft relinings of dentures. The product is composed of denture relining Soft/Extra Soft, Primer (Primer R and Primer M) and Modifier and Silicone Points. Two types are available, Soft and Extra Soft.

Source page: https://510kreport.com/device/K990736
Methodology: https://510kreport.com/methodology