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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 / K261404

510(k) cleared

UltraEZ

Ultradent Products, Inc. · Apr 30, 2026 · K261404

FDA cleared the UltraEZ from Ultradent Products, Inc. on Apr 30, 2026 under K261404, a special 510(k) reviewed through the Third Party Review Program. The device falls under product code LBH, Varnish, Cavity, regulated at 21 CFR 872.3260 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Apr 29, 2026. The decision came 1 days later, inside the 90 FDA-day goal for a 510(k).

Ultradent Products, Inc. has one other decision in the tracker over the last 12 months: K262228 (Transcend Bulk Fill Flowable Composite).

Questions & Answers

What did FDA clear under K261404?

K261404 is the FDA 510(k) for UltraEZ, submitted by Ultradent Products, Inc.. FDA's decision date was Apr 30, 2026, under product code LBH (Varnish, Cavity).

Who makes the UltraEZ?

Ultradent Products, Inc., based in South Jordan, UT, is the applicant of record for K261404.

How long did the K261404 review take?

FDA received the submission on Apr 29, 2026 and issued its decision on Apr 30, 2026, 1 days later.

← All decisions in April 2026

Sources