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)— 510(k) K252035

Substantially Equivalent

Kamemizu Chemical Industry Co., Ltd.

FDA 510(k) clearance K252035 for 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), Substantially Equivalent on 2025-09-17. Applicant: Kamemizu Chemical Industry Co., Ltd..

Clearance details

Applicant: Kamemizu Chemical Industry Co., Ltd.
Product code: Code EBI
Advisory panel: Dental
Date received: 2025-06-30
Decision date: 2025-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Neyagawa, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code EBI

product code EBI

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.