Impla-NX (Model: ISE-270M)

Controller, Foot, Handpiece And Cord

MICRO-NX Co., Ltd.

The following data is part of a premarket notification filed by Micro-nx Co., Ltd. with the FDA for Impla-nx (model: Ise-270m).

Pre-market Notification Details

Device IDK201192
510k NumberK201192
Device Name:Impla-NX (Model: ISE-270M)
ClassificationController, Foot, Handpiece And Cord
Applicant MICRO-NX Co., Ltd. 37, Dalseong2chadong 3-ro, Guji-myeon, Dalseong-gun Daegu,  KR 711-891
ContactJong-kun Lee
CorrespondentPriscilla Chung
LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine,  CA  92620
Product CodeEBW  
CFR Regulation Number872.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-04
Decision Date2021-05-21

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