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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 K161923
Device Name J2A SLA Dental Implant System
Applicant
Kj Meditech Co., Ltd.
21, Cheomdan Venture-Ro
40 Beon-Gil, Buk-Gu
Gwangju,  KR 500-470
Applicant Contact Goong-san Nam
Correspondent
LK Consulting Group USA, Inc.
800 Roosevelt
Suite 417
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3640
Classification Product Code
DZE  
Subsequent Product Code
NHA  
Date Received07/13/2016
Decision Date 11/09/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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