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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 / March 2026 / K253565

510(k) cleared

SureSmile Software

Dentsply Sirona, Inc. · Mar 4, 2026 · K253565

FDA cleared the SureSmile Software from Dentsply Sirona, Inc. on Mar 4, 2026 under K253565, a traditional 510(k). The device falls under product code PNN, Orthodontic Software, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Nov 17, 2025. The decision came 107 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)), K251614 (Stainless Steel Surgical Kits), K253959 (Primevision 3D).

Questions & Answers

What did FDA clear under K253565?

K253565 is the FDA 510(k) for SureSmile Software, submitted by Dentsply Sirona, Inc.. FDA's decision date was Mar 4, 2026, under product code PNN (Orthodontic Software).

Who makes the SureSmile Software?

Dentsply Sirona, Inc., based in York, PA, is the applicant of record for K253565.

How long did the K253565 review take?

FDA received the submission on Nov 17, 2025 and issued its decision on Mar 4, 2026, 107 days later.

← All decisions in March 2026