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.
Summary
Dentsply Sirona's Primevision 3D is filed under product code OAS (X-Ray, Tomography, Computed, Dental). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 892.1750. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Dentsply Sirona filed from York, Pennsylvania. Review took 57 calendar days (December 10, 2025 to February 5, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Dentsply Sirona
- Product code
- Product 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
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