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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K202963
Device Name ELEC Master, ELEC Master Dual
Applicant
Mgnewton , Ltd.
472, Hanjanggun-Ro, Jain-Myeon
Gyeongsan-Si,  KR 38552
Applicant Contact Byoung-Wook Ahn
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/30/2020
Decision Date 05/05/2023
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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