# K081554: Tokuyama Tissuecare

- Pathway: 510(k) (Traditional)
- Applicant: Tokuyama Dental Corporation
- Decided: Mar 18, 2009 after 288 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 K933468 (1994). 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)
- K933468: Myerson's Permasoft Soft Reline Material, Austenal, Inc. (1994) Summary page 2.

## Indications for use
The TOKUYAMA TISSUECARE denture relining, repairing, or rebasing resin material kit is a tissue conditioner and temporary liner for removable dentures. It is a prescription device intended for short-term use for conditioning of soft tissue distorted or damaged by the wearing of ill-fitting dentures, and for use as a temporary lining to make existing dentures more comfortable immediately after tooth extraction or oral surgery.

Source page: https://510kreport.com/device/K081554
Methodology: https://510kreport.com/methodology