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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, No.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
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