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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 K212803
Device Name DailyMate 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 Received09/02/2021
Decision Date 05/23/2022
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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