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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K163117
Device Name Alpha Pure
Applicant
KOROAD AMERICA
895 DOVE ST, SUITE 300
NEWPORT BEACH,  CA  92660
Applicant Contact YEON JAE LEE
Correspondent
PROVISION CONSULTING GROUP INC.
3248 WILLOW HOLLOW RD
CHINO HILLS,  CA  91709
Correspondent Contact JOYCE BANG
Regulation Number872.5470
Classification Product Code
NJM  
Date Received11/07/2016
Decision Date 05/09/2017
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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