FDA 510(k)

Dental Ceramic

Número K: K182350 · 2019-05-22

RequerenteBaot Biological Technology Co., Ltd.

Data da decisão2019-05-22

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Baot Biological Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-05-22 under 510(k) number K182350. 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 Ceramic?

Dental Ceramic is a medical device that received FDA 510(k) clearance on 2019-05-22. The listed applicant is Baot Biological Technology Co., Ltd.. The 510(k) number is K182350.

When did Dental Ceramic receive FDA 510(k) clearance?

Dental Ceramic received FDA 510(k) clearance on 2019-05-22, under 510(k) number K182350.

Who is the listed applicant for Dental Ceramic?

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

What is the FDA product code for Dental Ceramic?

The FDA product code for Dental Ceramic 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.

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