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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 / K251614

510(k) cleared

Stainless Steel Surgical Kits

Dentsply Sirona, Inc. · Feb 6, 2026 · K251614

FDA cleared the Stainless Steel Surgical Kits from Dentsply Sirona, Inc. on Feb 6, 2026 under K251614, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 27, 2025. The decision came 255 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), K253959 (Primevision 3D).

Questions & Answers

What did FDA clear under K251614?

K251614 is the FDA 510(k) for Stainless Steel Surgical Kits, submitted by Dentsply Sirona, Inc.. FDA's decision date was Feb 6, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the Stainless Steel Surgical Kits?

Dentsply Sirona, Inc., based in York, PA, is the applicant of record for K251614.

How long did the K251614 review take?

FDA received the submission on May 27, 2025 and issued its decision on Feb 6, 2026, 255 days later.

← All decisions in February 2026