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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253959

510(k) cleared

Primevision 3D

Dentsply Sirona · Feb 5, 2026 · K253959

FDA cleared the Primevision 3D from Dentsply Sirona on Feb 5, 2026 under K253959, a traditional 510(k). The device falls under product code OAS, X-Ray, Tomography, Computed, Dental, regulated at 21 CFR 892.1750 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Dec 10, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

Dentsply Sirona has 8 other decisions in the tracker over the last 12 months: K260785 (DS Core CBCT Anatomy), K260722 (SureSmile Aligner (ASSY500020)), K253565 (SureSmile Software), K251614 (Stainless Steel Surgical Kits).

Questions & Answers

What did FDA clear under K253959?

K253959 is the FDA 510(k) for Primevision 3D, submitted by Dentsply Sirona. FDA's decision date was Feb 5, 2026, under product code OAS (X-Ray, Tomography, Computed, Dental).

Who makes the Primevision 3D?

Dentsply Sirona, based in York, PA, is the applicant of record for K253959.

How long did the K253959 review take?

FDA received the submission on Dec 10, 2025 and issued its decision on Feb 5, 2026, 57 days later.

← All decisions in February 2026