K253959
- 510(k) number
- K253959
- Device name
- Primevision 3D
- Applicant
- Dentsply Sirona PA · US
- Product code
- OAS — X-Ray, Tomography, Computed, Dental
- Decision date
- 2026-02-05
- Date received
- 2025-12-10
- 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: K253959.pdf
Official FDA record: K253959
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.