Micro-Nx Co., Ltd. is one of 351 FDA 510(k) medical device manufacturers from South Korea in the dataset, ranked by real submission volume.
Micro-Nx Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: ELEC ENGINE (Model: ISE-170L), Dental Handpiece, Wireless Endodontic Handpiece, endoit, Dental Handpiece, Model CA160, CA160L, and CA500L
7
Total
7
Cleared
0
Denied
Micro-Nx Co., Ltd. has 7 FDA 510(k) cleared medical devices. Based in Daegu, KR.
Latest FDA clearance: Jul 2025. Active since 2017. Primary specialty: Dental.
Browse the FDA 510(k) cleared devices submitted by Micro-Nx Co., Ltd. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by LK Consulting Group USA, Inc. and K-Bio Solutions.
FDA 510(k) Regulatory Record - Micro-Nx Co., Ltd.
7 devices
Cleared
Jul 18, 2025
ELEC ENGINE (Model: ISE-170L)
Dental
779d
Cleared
Nov 09, 2023
Dental Handpiece, Wireless Endodontic Handpiece, endoit
Dental
58d
Cleared
Jul 29, 2022
Dental Handpiece, Model CA160, CA160L, and CA500L
Dental
151d
Cleared
Feb 07, 2022
ELEC-LED
Dental
644d
Cleared
May 21, 2021
Impla-NX (Model: ISE-270M)
Dental
382d
Cleared
Aug 25, 2020
Dental Handpiece
Dental
329d
Cleared
Feb 22, 2017
MEG-TORQ
Dental
266d