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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 / K252465

510(k) cleared

Any-Core

Mediclus Co., Ltd. · Dec 5, 2025 · K252465

FDA cleared the Any-Core from Mediclus Co., Ltd. on Dec 5, 2025 under K252465, a traditional 510(k). The device falls under product code EBF, Material, Tooth Shade, Resin, regulated at 21 CFR 872.3690 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Aug 6, 2025. The decision came 121 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: K254201 (Any-Cem), K261728 (One-Fil LC), K260485 (Any-Etch), K260819 (Any-Com Seal).

Questions & Answers

What did FDA clear under K252465?

K252465 is the FDA 510(k) for Any-Core, submitted by Mediclus Co., Ltd.. FDA's decision date was Dec 5, 2025, under product code EBF (Material, Tooth Shade, Resin).

Who makes the Any-Core?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K252465.

How long did the K252465 review take?

FDA received the submission on Aug 6, 2025 and issued its decision on Dec 5, 2025, 121 days later.

← All decisions in December 2025

Sources