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The Tracker / August 2026 / K262074

510(k) cleared

Any-Zircos

Mediclus Co., Ltd. · Aug 21, 2026 · K262074

FDA cleared the Any-Zircos from Mediclus Co., Ltd. on Aug 21, 2026 under K262074, a traditional 510(k). The device falls under product code EIH, Powder, Porcelain, regulated at 21 CFR 872.6660 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 22, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Mediclus Co., Ltd. has 7 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 K262074?

K262074 is the FDA 510(k) for Any-Zircos, submitted by Mediclus Co., Ltd.. FDA's decision date was Aug 21, 2026, under product code EIH (Powder, Porcelain).

Who makes the Any-Zircos?

Mediclus Co., Ltd., based in Cheongju-Si, is the applicant of record for K262074.

How long did the K262074 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Aug 21, 2026, 60 days later.

← All decisions in August 2026

Sources