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)
FDA 510(k) clearance K252035 · decided 2025-09-17
Clearance details
- 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.
- Decision
- Substantially Equivalent
- Date received
- 2025-06-30
- Decision date
- 2025-09-17
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Neyagawa, JP
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.