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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 / August 2026 / K254201

510(k) cleared

Any-Cem

Mediclus Co., Ltd. · Aug 13, 2026 · K254201

FDA cleared the Any-Cem from Mediclus Co., Ltd. on Aug 13, 2026 under K254201, 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 29, 2025. The decision came 227 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Mediclus Co., Ltd. has 6 other decisions in the tracker over the last 12 months: K261728 (One-Fil LC), K260485 (Any-Etch), K260819 (Any-Com Seal), K253797 (One-Stop).

Questions & Answers

What did FDA clear under K254201?

K254201 is the FDA 510(k) for Any-Cem, submitted by Mediclus Co., Ltd.. FDA's decision date was Aug 13, 2026, under product code EMA (Cement, Dental).

Who makes the Any-Cem?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K254201.

How long did the K254201 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Aug 13, 2026, 227 days later.

← All decisions in August 2026

Sources