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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 K202046
Device Name LOTA SLA Dental Implant System and LOTA HA Dental Implant System
Applicant
Kj Meditech Co., Ltd.
959-21 Daechon-Dong, Buk-Gu
Gwang-Ju,  KR
Applicant Contact Hyukki Moon
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 03/01/2022
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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