FDA 510(k)

Any-Cem

K-Number: K254201 · 2026-08-13

Decision Date2026-08-13

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Any-Cem is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-08-13 under 510(k) number K254201. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Any-Cem?

Any-Cem is a medical device that received FDA 510(k) clearance on 2026-08-13. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K254201.

When did Any-Cem receive FDA 510(k) clearance?

Any-Cem received FDA 510(k) clearance on 2026-08-13, under 510(k) number K254201.

Who is the listed applicant for Any-Cem?

The FDA 510(k) record lists Mediclus Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Any-Cem?

The FDA product code for Any-Cem is EMA.

Other records listing Mediclus Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: EMA)

K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH K254063iCEM Universal PlusKulzer, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.