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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
3D Global Biotech Inc.
21F.-1, No.99, Sec. 1, Xintai 5th Rd., Xizhi Dist.,
New Taipei City 221,  TW
Applicant Contact Keng-Liang Ou
DuoCare, LLC
370 W Grand Blvd #110,
Corona,  CA  92882
Correspondent Contact Diana Lam
Regulation Number872.5470
Classification Product Code
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