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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 K173116
Device Name KJ ZIRCONIA Implant System
Applicant
Kj Meditech Co., Ltd.
21, Cheomdan Venture-Ro,
40 Beon-Gil, Buk-Gu
Gwangju,  KR 500-470
Applicant Contact Hyukki Moon
Correspondent
LK Consulting Group USA, Inc.
690 Roosevelt
690 Roosevelt,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/29/2017
Decision Date 06/28/2018
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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