K250489
- 510(k) number
- K250489
- Device name
- FP3D
- Applicant
- Keystone Industries NJ · US
- Product code
- EBI — Resin, Denture, Relining, Repairing, Rebasing
- Decision date
- 2025-05-20
- Date received
- 2025-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K250489.pdf
Official FDA record: K250489
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.