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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 K223395
Device Name Luna Dental Implant System
Applicant
Shinhung Mst Co., Ltd.
110-2, Donghwagongdan-Ro, Munmak-Eup
Wonju-Si,  KR 26365
Applicant Contact Sun Ho Lee
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman, Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/08/2022
Decision Date 02/03/2023
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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