FDA 510(k)

Dental Glass Ceramics Blocks

Número K: K232438 · 2023-12-01

RequerenteAibodent Biotechnology Co., Ltd.

Data da decisão2023-12-01

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Glass Ceramics Blocks is the device name listed in this FDA 510(k) record. The listed applicant is Aibodent Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-01 under 510(k) number K232438. 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 Dental Glass Ceramics Blocks?

Dental Glass Ceramics Blocks is a medical device that received FDA 510(k) clearance on 2023-12-01. The listed applicant is Aibodent Biotechnology Co., Ltd.. The 510(k) number is K232438.

When did Dental Glass Ceramics Blocks receive FDA 510(k) clearance?

Dental Glass Ceramics Blocks received FDA 510(k) clearance on 2023-12-01, under 510(k) number K232438.

Who is the listed applicant for Dental Glass Ceramics Blocks?

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

What is the FDA product code for Dental Glass Ceramics Blocks?

The FDA product code for Dental Glass Ceramics Blocks 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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