# K252035: DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White set); DENTURE SOFT EX (Pink powder); DENTURE SPFT EX (White powder); DENTURE SOFT EX (Liquid); DENTURE SOFT EX (Trial kit Pink); DENTURE SOFT EX (Trial kit White)

- Pathway: 510(k) (Traditional)
- Applicant: Kamemizu Chemical Industry Co., Ltd.
- Decided: Sep 17, 2025 after 79 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 K070698 (2007). 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)
- K070698: Coe Comfort, GC America, Inc. (2007) Summary page 5.

## Indications for use
It is a soft acrylic resin used to line the denture base. It is a tissue conditioner. By lining the mucous membrane side of dentures, it is used for temporary relining, tissue conditioning, and obtaining functional impressions.

Source page: https://510kreport.com/device/K252035
Methodology: https://510kreport.com/methodology