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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 / January 2026 / K253009

510(k) cleared

DS Core Detect

Dentsply Sirona, Inc. · Jan 7, 2026 · K253009

FDA cleared the DS Core Detect from Dentsply Sirona, Inc. on Jan 7, 2026 under K253009, a traditional 510(k). The device falls under product code MYN, Analyzer, Medical Image, regulated at 21 CFR 892.2070 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Sep 19, 2025. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Dentsply Sirona, Inc. 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 K253009?

K253009 is the FDA 510(k) for DS Core Detect, submitted by Dentsply Sirona, Inc.. FDA's decision date was Jan 7, 2026, under product code MYN (Analyzer, Medical Image).

Who makes the DS Core Detect?

Dentsply Sirona, Inc., based in York, PA, is the applicant of record for K253009.

How long did the K253009 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Jan 7, 2026, 110 days later.

← All decisions in January 2026