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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 / December 2025 / K254063

510(k) cleared

iCEM Universal Plus

Kulzer, LLC · Dec 19, 2025 · K254063

FDA cleared the iCEM Universal Plus from Kulzer, LLC on Dec 19, 2025 under K254063, a abbreviated 510(k) reviewed through the Third Party Review Program. The device falls under product code EMA, Cement, Dental, regulated at 21 CFR 872.3275 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 17, 2025. The decision came 2 days later, inside the 90 FDA-day goal for a 510(k).

Kulzer, LLC has 2 other decisions in the tracker over the last 12 months: K260783 (Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One), K243910 (Retraxil).

Questions & Answers

What did FDA clear under K254063?

K254063 is the FDA 510(k) for iCEM Universal Plus, submitted by Kulzer, LLC. FDA's decision date was Dec 19, 2025, under product code EMA (Cement, Dental).

Who makes the iCEM Universal Plus?

Kulzer, LLC, based in South Bend, IN, is the applicant of record for K254063.

How long did the K254063 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on Dec 19, 2025, 2 days later.

← All decisions in December 2025

Sources