DENTURE SOFT EX (Pink set) +6 more— 510(k) K252035

Name: FDA 510(k) clearance K252035
Creator: U.S. Food and Drug Administration
Published: 2025-09-17

Substantially Equivalent

Kamemizu Chemical Industry Co., Ltd.

FDA 510(k) clearance K252035 for DENTURE SOFT EX (Pink set) +6 more, Substantially Equivalent on 2025-09-17. Applicant: Kamemizu Chemical Industry Co., Ltd.. Device class: 2.

Clearance details

Device name as filed: 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)
Applicant: Kamemizu Chemical Industry Co., Ltd.
Product code: Code EBI
Device class: Class 2
Regulation: 21 CFR 872.3760
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 ↗

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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.