Custom-made Invisible Aligners

Aligner, Sequential

Zhejiang Yinchili Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Zhejiang Yinchili Medical Technology Co., Ltd. with the FDA for Custom-made Invisible Aligners.

Pre-market Notification Details

Device IDK203624
510k NumberK203624
Device Name:Custom-made Invisible Aligners
ClassificationAligner, Sequential
Applicant Zhejiang Yinchili Medical Technology Co., Ltd. North 4F, Building 1, No. 239 Yatai Road, Daqiao Town, Nanhu District Jiaxing,  CN
ContactHangli Chen
CorrespondentIvy Wang
Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai,  CN 200122
Product CodeNXC  
CFR Regulation Number872.5470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2022-06-16

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