FDA 510(k)

Zirconia Dental Ceramics

Número K: K170894 · 2017-08-01

RequerenteChengdu Besmile Biotechnology Co., Ltd.

Data da decisão2017-08-01

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Zirconia Dental Ceramics is the device name listed in this FDA 510(k) record. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2017-08-01 under 510(k) number K170894. 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 Zirconia Dental Ceramics?

Zirconia Dental Ceramics is a medical device that received FDA 510(k) clearance on 2017-08-01. The listed applicant is Chengdu Besmile Biotechnology Co., Ltd.. The 510(k) number is K170894.

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

Zirconia Dental Ceramics received FDA 510(k) clearance on 2017-08-01, under 510(k) number K170894.

Who is the listed applicant for Zirconia Dental Ceramics?

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

What is the FDA product code for Zirconia Dental Ceramics?

The FDA product code for Zirconia Dental Ceramics 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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