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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 / July 2026 / K261166

510(k) cleared

DIA-CEM

DiaDent Group International · Jul 9, 2026 · K261166

FDA cleared the DIA-CEM from DiaDent Group International on Jul 9, 2026 under K261166, 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 Apr 9, 2026. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

DiaDent Group International has 3 other decisions in the tracker over the last 12 months: K261093 (DIAFIL), K261071 (DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)), K254112 (Dia-X Sil Bite).

Questions & Answers

What did FDA clear under K261166?

K261166 is the FDA 510(k) for DIA-CEM, submitted by DiaDent Group International. FDA's decision date was Jul 9, 2026, under product code EMA (Cement, Dental).

Who makes the DIA-CEM?

DiaDent Group International, based in Cheongju-Si, is the applicant of record for K261166.

How long did the K261166 review take?

FDA received the submission on Apr 9, 2026 and issued its decision on Jul 9, 2026, 91 days later.

← All decisions in July 2026

Sources