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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 K223454
Device Name Custom-made Invisible Aligners
Zhejiang Yinchili Medical Technology Co., Ltd.
North 4F, No.239 Yatai Road
Nanhu District
Jiaxing,  CN 314000
Applicant Contact Xinyan Zhang
Shanghai Sungo Management Consulting Company Limited
14th Floor, 1500# Central Avenue
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number872.5470
Classification Product Code
Date Received11/16/2022
Decision Date 04/17/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No