FDA 510(k)

Ceramic Denture Zirconia Ceramics Block

Número K: K181816 · 2018-11-29

RequerenteQinhuangdao Silide Ceramic Technology Co., Ltd.

Data da decisão2018-11-29

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ceramic Denture Zirconia Ceramics Block is the device name listed in this FDA 510(k) record. The listed applicant is Qinhuangdao Silide Ceramic Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-11-29 under 510(k) number K181816. 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 Ceramic Denture Zirconia Ceramics Block?

Ceramic Denture Zirconia Ceramics Block is a medical device that received FDA 510(k) clearance on 2018-11-29. The listed applicant is Qinhuangdao Silide Ceramic Technology Co., Ltd.. The 510(k) number is K181816.

When did Ceramic Denture Zirconia Ceramics Block receive FDA 510(k) clearance?

Ceramic Denture Zirconia Ceramics Block received FDA 510(k) clearance on 2018-11-29, under 510(k) number K181816.

Who is the listed applicant for Ceramic Denture Zirconia Ceramics Block?

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

What is the FDA product code for Ceramic Denture Zirconia Ceramics Block?

The FDA product code for Ceramic Denture Zirconia Ceramics Block 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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