Primevision 3D— 510(k) K253959
Substantially EquivalentDentsply Sirona
FDA 510(k) clearance K253959 for Primevision 3D, Substantially Equivalent on 2026-02-05. Applicant: Dentsply Sirona. Device class: 2.
Clearance details
- Applicant
- Dentsply Sirona
- Product code
- Code OAS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1750
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- York, PA, US
Recent devices under product code OAS
view allMore clearances from Dentsply Sirona
view allData sourced from openFDA. This site is unofficial and independent of the FDA.