K252035
- 510(k) number
- K252035
- Device name
- 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. JP
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2025-09-17
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252035.pdf
Official FDA record: K252035
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.