Cleared Traditional

Primevision 3D

K253959 · Dentsply Sirona · Radiology

Feb 2026

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K253959 is an FDA 510(k) clearance for the Primevision 3D, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Dentsply Sirona (York, US). The FDA issued a Cleared decision on February 5, 2026, 57 days after receiving the submission on December 10, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number	K253959 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2025
Decision Date	February 05, 2026
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	OAS — X-ray, Tomography, Computed, Dental
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 892.1750
Definition	Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.