Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Powder, Porcelain

Hunan Vsmile Biotechnology Co., Ltd

The following data is part of a premarket notification filed by Hunan Vsmile Biotechnology Co., Ltd with the FDA for Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-shaded Blank.

Pre-market Notification Details

Device IDK221242
510k NumberK221242
Device Name:Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
ClassificationPowder, Porcelain
Applicant Hunan Vsmile Biotechnology Co., Ltd Juxing 501-5,501-6, Lujing Road No.8, Lugu High-tech Zone Changsha,  CN 410000
ContactXiaomi Tang
CorrespondentShanfeng Jiang
Guangzhou Junyi Information Technology Co., Ltd. Room 304, Building A, No. 62 Nanyun 2nd Road, Science Town Huangpu District, Guangzhou City,  CN 510663
Product CodeEIH  
CFR Regulation Number872.6660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-02
Decision Date2022-07-29

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