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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
Predetermined Change
Control Plan Authorized		 No
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