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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abutment, Implant, Dental, Endosseous
510(k) Number K200189
Device Name Luna Dental Implant System- Healing Abutment
Applicant
Shinhung Mst Co., Ltd.
110-2, Donghwagong-Ro Munmak-Eup
Wonju Si,  KR 220-801
Applicant Contact Jae Soo Song
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.3630
Classification Product Code
NHA  
Date Received01/27/2020
Decision Date 02/26/2020
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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