Clear Aligners

Aligner, Sequential

Shenzhen Yinuo Dental Technology Co.LTD

The following data is part of a premarket notification filed by Shenzhen Yinuo Dental Technology Co.ltd with the FDA for Clear Aligners.

Pre-market Notification Details

Device IDK210373
510k NumberK210373
Device Name:Clear Aligners
ClassificationAligner, Sequential
Applicant Shenzhen Yinuo Dental Technology Co.LTD Xinfeng Industry Park No.11,101-301,Xintian Community, Guanhu Street, Longhua Shenzhen,  CN 518000
ContactMo Yuyum
CorrespondentGamma Zhang
Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou,  CN 510000
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-08
Decision Date2021-08-27

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