FDA 510(k)

Dental Lithium Disilicate Glass-Ceramic

Número K: K230487 · 2023-07-03

RequerenteFuzhou Rick Brown Biomaterials Co., Ltd.

Data da decisão2023-07-03

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Dental Lithium Disilicate Glass-Ceramic is the device name listed in this FDA 510(k) record. The listed applicant is Fuzhou Rick Brown Biomaterials Co., Ltd.. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K230487. 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 Lithium Disilicate Glass-Ceramic?

Dental Lithium Disilicate Glass-Ceramic is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Fuzhou Rick Brown Biomaterials Co., Ltd.. The 510(k) number is K230487.

When did Dental Lithium Disilicate Glass-Ceramic receive FDA 510(k) clearance?

Dental Lithium Disilicate Glass-Ceramic received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230487.

Who is the listed applicant for Dental Lithium Disilicate Glass-Ceramic?

The FDA 510(k) record lists Fuzhou Rick Brown Biomaterials Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dental Lithium Disilicate Glass-Ceramic?

The FDA product code for Dental Lithium Disilicate Glass-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.

Fonte oficial

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