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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 / K253282

510(k) cleared

ZSmile System

Dror Orthodesign , Ltd. · Feb 3, 2026 · K253282

FDA cleared the ZSmile System from Dror Orthodesign , Ltd. on Feb 3, 2026 under K253282, a special 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 Sep 29, 2025. The decision came 127 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Dror Orthodesign , Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253282?

K253282 is the FDA 510(k) for ZSmile System, submitted by Dror Orthodesign , Ltd.. FDA's decision date was Feb 3, 2026, under product code NXC (Aligner, Sequential).

Who makes the ZSmile System?

Dror Orthodesign , Ltd., based in Jerusalem, is the applicant of record for K253282.

How long did the K253282 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Feb 3, 2026, 127 days later.

← All decisions in February 2026