FDA 510(k)

Dental Zirconia Blocks

Número K: K192262 · 2020-05-29

Data da decisão2020-05-29

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Zirconia Blocks is the device name listed in this FDA 510(k) record. The listed applicant is De Corematrix Co., Ltd.. It received FDA 510(k) clearance on 2020-05-29 under 510(k) number K192262. 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 Zirconia Blocks?

Dental Zirconia Blocks is a medical device that received FDA 510(k) clearance on 2020-05-29. The listed applicant is De Corematrix Co., Ltd.. The 510(k) number is K192262.

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

Dental Zirconia Blocks received FDA 510(k) clearance on 2020-05-29, under 510(k) number K192262.

Who is the listed applicant for Dental Zirconia Blocks?

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

What is the FDA product code for Dental Zirconia Blocks?

The FDA product code for Dental Zirconia 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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