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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 / K260722

510(k) cleared

SureSmile Aligner (ASSY500020)

Dentsply Sirona, Inc. · Apr 15, 2026 · K260722

FDA cleared the SureSmile Aligner (ASSY500020) from Dentsply Sirona, Inc. on Apr 15, 2026 under K260722, a traditional 510(k). The device falls under product code NXC, Aligner, Sequential, regulated at 21 CFR 872.5470 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Mar 5, 2026. The decision came 41 days later, inside the 90 FDA-day goal for a 510(k).

Dentsply Sirona, Inc. has 8 other decisions in the tracker over the last 12 months: K260785 (DS Core CBCT Anatomy), K253565 (SureSmile Software), K251614 (Stainless Steel Surgical Kits), K253959 (Primevision 3D).

Questions & Answers

What did FDA clear under K260722?

K260722 is the FDA 510(k) for SureSmile Aligner (ASSY500020), submitted by Dentsply Sirona, Inc.. FDA's decision date was Apr 15, 2026, under product code NXC (Aligner, Sequential).

Who makes the SureSmile Aligner (ASSY500020)?

Dentsply Sirona, Inc., based in York, PA, is the applicant of record for K260722.

How long did the K260722 review take?

FDA received the submission on Mar 5, 2026 and issued its decision on Apr 15, 2026, 41 days later.

← All decisions in April 2026