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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 / May 2026 / K254109

510(k) cleared

G-CEM UNIVERSAL

GC America, Inc. · May 18, 2026 · K254109

FDA cleared the G-CEM UNIVERSAL from GC America, Inc. on May 18, 2026 under K254109, 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 Dec 19, 2025. The decision came 150 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

GC America, Inc. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K254109?

K254109 is the FDA 510(k) for G-CEM UNIVERSAL, submitted by GC America, Inc.. FDA's decision date was May 18, 2026, under product code EMA (Cement, Dental).

Who makes the G-CEM UNIVERSAL?

GC America, Inc., based in Alsip, IL, is the applicant of record for K254109.

How long did the K254109 review take?

FDA received the submission on Dec 19, 2025 and issued its decision on May 18, 2026, 150 days later.

← All decisions in May 2026