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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 K191837
Device Name UniSmile Clear Aligner System
Applicant
Vitang Technology, LLC
14662 Franklin Ave, Unit H
Tustin,  CA  92780
Applicant Contact Xiangxu Chen
Correspondent
Vitang Technology, LLC
14662 Franklin Ave, Unit H
Tustin,  CA  92780
Correspondent Contact Xiangxu Chen
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/09/2019
Decision Date 01/29/2020
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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