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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K231562
Device Name ELEC ENGINE (Model: ISE-170L)
Applicant
Micro-Nx Co., Ltd.
22, Maeyeo-Ro 1-Gil, Dong-Gu
Daegu,  KR 41059
Applicant Contact Lee Jong Kun
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number872.4200
Classification Product Code
EBW  
Date Received05/31/2023
Decision Date 07/18/2025
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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