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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K160536
Device Name Chaorum Implant System
Applicant
Medimecca Co., Ltd.
Daeryung Techno Town 3-Cha 104, 105, 109, 110,
Gasan-Dong,115
Seoul,  KR 153-772
Applicant Contact PARK YOUNG WAN
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt Suite 417
Irvine,  CA  92606
Correspondent Contact PRISCILLA CHUNG
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received02/26/2016
Decision Date 01/05/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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