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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 / K260485

510(k) cleared

Any-Etch

Mediclus Co., Ltd. · May 14, 2026 · K260485

FDA cleared the Any-Etch from Mediclus Co., Ltd. on May 14, 2026 under K260485, a traditional 510(k). The device falls under product code KLE, Agent, Tooth Bonding, Resin, regulated at 21 CFR 872.3200 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Feb 13, 2026. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

Mediclus Co., Ltd. has 6 other decisions in the tracker over the last 12 months: K254201 (Any-Cem), K261728 (One-Fil LC), K260819 (Any-Com Seal), K253797 (One-Stop).

Questions & Answers

What did FDA clear under K260485?

K260485 is the FDA 510(k) for Any-Etch, submitted by Mediclus Co., Ltd.. FDA's decision date was May 14, 2026, under product code KLE (Agent, Tooth Bonding, Resin).

Who makes the Any-Etch?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K260485.

How long did the K260485 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on May 14, 2026, 90 days later.

← All decisions in May 2026

Sources