Primevision 3D
FDA 510(k) K253959 · Dentsply Sirona
510(k) numberK253959
Submission
- Device name
- Primevision 3D
- Applicant
- Dentsply Sirona
York, PA, US - Received
- December 10, 2025
- Decision date
- February 5, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Primevision 3D cleared by the FDA?
Primevision 3D (K253959) received a 510(k) decision of Substantially Equivalent on February 5, 2026, 57 days after the submission was received.
What is the product code of K253959?
The FDA product code is OAS – X-Ray, Tomography, Computed, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1750.