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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
Shinhung MST Co., Ltd
110-2, Donghwagongdan-ro, Munmak-Eup
Wonju-Si,  KR 26365
Applicant Contact Sun Ho Lee
Lk Consulting Group USA, Inc
18881 Von Karman, STE 160
IRVINE,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.3630
Classification Product Code
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