FDA 510(k)

X-cera Zirconia Blanks

Número K: K153767 · 2016-03-29

RequerenteShenzhen Xiangtong Photoelectricity Technology Co., Ltd.

Data da decisão2016-03-29

Código do produtoEIH

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

X-cera Zirconia Blanks is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-03-29 under 510(k) number K153767. 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 X-cera Zirconia Blanks?

X-cera Zirconia Blanks is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. The 510(k) number is K153767.

When did X-cera Zirconia Blanks receive FDA 510(k) clearance?

X-cera Zirconia Blanks received FDA 510(k) clearance on 2016-03-29, under 510(k) number K153767.

Who is the listed applicant for X-cera Zirconia Blanks?

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

What is the FDA product code for X-cera Zirconia Blanks?

The FDA product code for X-cera Zirconia Blanks 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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