FDA 510(k)

DCMhotbond zircon

Número K: K253191 · 2026-05-21

RequerenteDental Creativ Management GmbH

Data da decisão2026-05-21

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Dispositivos Relacionados (Código: EIH)

K262074Any-ZircosMediclus Co., Ltd.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.

Fonte oficial

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