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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name aligner, sequential
510(k) Number K203624
Device Name Custom-made Invisible Aligners
Applicant
Zhejiang Yinchili Medical Technology Co., Ltd.
North 4F, Building 1, No. 239 Yatai Road, Daqiao Town,
Nanhu District
Jiaxing,  CN
Applicant Contact Hangli Chen
Correspondent
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/11/2020
Decision Date 06/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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