FDA · official record K252035Substantially EquivalentDENTURE 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)
United StatesEBIKamemizu Chemical Industry Co., Ltd.
Official record identity
- FDA application number
- K252035
- Decision date
- September 17, 2025
- Published decision
- Substantially Equivalent
Classification
Published parties
- Applicant
- Kamemizu Chemical Industry Co., Ltd.
Additional source fields
- Decision code
- SESE
- Published decision
- Substantially Equivalent
- Submission type
- Traditional
- Received date
- 2025-06-30
- Review panel
- Dental
- Current product-code class (harmonized)
- 2
- Current product-code regulation (harmonized)
- 872.3760
About this record
This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.