K250302
- 510(k) number
- K250302
- Device name
- Flexible Partial Resin
- Applicant
- Prismatik Dentalcraft, Inc. CA · US
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2025-06-25
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K250302.pdf
Official FDA record: K250302
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.