FDA 510(k)

DCMhotbond zircon

K-Number: K253191 · 2026-05-21

Decision Date2026-05-21

Product CodeEIH

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DCMhotbond zircon is the device name listed in this FDA 510(k) record. The listed applicant is Dental Creativ Management GmbH. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K253191. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DCMhotbond zircon?

DCMhotbond zircon is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is Dental Creativ Management GmbH. The 510(k) number is K253191.

When did DCMhotbond zircon receive FDA 510(k) clearance?

DCMhotbond zircon received FDA 510(k) clearance on 2026-05-21, under 510(k) number K253191.

Who is the listed applicant for DCMhotbond zircon?

The FDA 510(k) record lists Dental Creativ Management GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCMhotbond zircon?

The FDA product code for DCMhotbond zircon is EIH.

Related Devices (Code: EIH)

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.

K262239Obsidian® Press Over ZirconiaPrismatik Dentalcraft, Inc.K261046Dental Zirconia Blank & Coloring LiquidHunan Qinghao Puzhong Technology Co., Ltd.K262195Dandy Ceramic Stain and GlazeZima International Inc., dba Dandy K260918Zolid LunarisAmann Girrbach AG K260859Rosetta SM, Rosetta SPHass Corp.K260067Eternal Art Porcelain PowdersShandong Huge Dental Material Corporation

Official Source

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