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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K152766
Device Name CharmFlex
Applicant
Dentkist, Inc.
(Dangjeong-Dong) 3, Nongsim-Ro
Gunpo-Si,  KR 15842
Applicant Contact SHIN HEANG LEE
Correspondent
Plusglobal
300, Atwood
Pittsburgh,  PA  15213
Correspondent Contact PETER CHUNG
Regulation Number872.3660
Classification Product Code
ELW  
Date Received09/24/2015
Decision Date 03/08/2016
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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