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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 / April 2026 / K260785

510(k) cleared

DS Core CBCT Anatomy

Dentsply Sirona · Apr 23, 2026 · K260785

FDA cleared the DS Core CBCT Anatomy from Dentsply Sirona on Apr 23, 2026 under K260785, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 10, 2026. The decision came 44 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: K260722 (SureSmile Aligner (ASSY500020)), K253565 (SureSmile Software), K251614 (Stainless Steel Surgical Kits), K253959 (Primevision 3D).

Questions & Answers

What did FDA clear under K260785?

K260785 is the FDA 510(k) for DS Core CBCT Anatomy, submitted by Dentsply Sirona. FDA's decision date was Apr 23, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the DS Core CBCT Anatomy?

Dentsply Sirona, based in York, PA, is the applicant of record for K260785.

How long did the K260785 review take?

FDA received the submission on Mar 10, 2026 and issued its decision on Apr 23, 2026, 44 days later.

← All decisions in April 2026