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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 K202039
Device Name Honorst Implant System
Applicant
Medimecca Co., Ltd.
Daeryung Techno Town 3-Cha 104,105, 109, 110 Gasan-Dong, 115
Seoul,  KR 08505
Applicant Contact Seung Yoon Lee
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/23/2020
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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