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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 K191774
Device Name SmileAlign Orthodontic Aligner System
Applicant
3D Global Biotech, Inc.
21f.-1, #99, Sec. 1, Xintai 5th Rd., Xizhi Dist.,
New Taipei City 221,  TW
Applicant Contact Keng-Liang Ou
Correspondent
Duocare, LLC
370 W Grand Blvd. #110
Corona,  CA  92882
Correspondent Contact Diana Lam
Regulation Number872.5470
Classification Product Code
NXC  
Date Received07/02/2019
Decision Date 09/30/2019
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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