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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 / K253337

510(k) cleared

REGEN Bioactive Cement

Inter-Med, Inc. · Apr 15, 2026 · K253337

FDA cleared the REGEN Bioactive Cement from Inter-Med, Inc. on Apr 15, 2026 under K253337, a traditional 510(k). 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 Sep 30, 2025. The decision came 197 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 Inter-Med, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253337?

K253337 is the FDA 510(k) for REGEN Bioactive Cement, submitted by Inter-Med, Inc.. FDA's decision date was Apr 15, 2026, under product code EMA (Cement, Dental).

Who makes the REGEN Bioactive Cement?

Inter-Med, Inc., based in Racine, WI, is the applicant of record for K253337.

How long did the K253337 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Apr 15, 2026, 197 days later.

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