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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 K201192
Device Name Impla-NX (Model: ISE-270M)
Applicant
Micro-Nx Co., Ltd.
37, Dalseong2chadong 3-Ro, Guji-Myeon, Dalseong-Gun
Daegu,  KR 711-891
Applicant Contact Jong-Kun Lee
Correspondent
LK Consulting Group USA, Inc.
1150 Roosevelt Suite 200
Irvine,  CA  92620
Correspondent Contact Priscilla Chung
Regulation Number872.4200
Classification Product Code
EBW  
Date Received05/04/2020
Decision Date 05/21/2021
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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