510(k) 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) by
Kamemizu Chemical Industry Co., Ltd.
— Product Code EBI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 17, 2025
- Date Received
- June 30, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resin, Denture, Relining, Repairing, Rebasing
- Device Class
- Class II
- Regulation Number
- 872.3760
- Review Panel
- DE
- Submission Type