K250753
- 510(k) number
- K250753
- Device name
- VELMENI for DENTISTS (V4D)
- Applicant
- Velmeni, Inc. CA · US
- Product code
- MYN — Analyzer, Medical Image
- Decision date
- 2025-09-02
- Date received
- 2025-03-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250753.pdf
Official FDA record: K250753
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.