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Medical DevicesKONEX 44878050 approvals

Micro-NX Co., Ltd.

Official website

Micro-NX develops proprietary BLDC motor technology and manufactures dental medical devices including implant engines and torque drivers.

As of 2026-10-10, Micro-NX Co., Ltd. has 43 Korean MFDS device approvals, 7 US FDA clearances/approvals on record (counted by the MAA Company Index from its own matching of public databases).

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Business overview

Source: DART corporate disclosure

Founded in 2001 and listed on KONEX in 2022, Micro-NX is a dental medical device company. Using its own BLDC motor technology, it makes the ELEC ENGINE implant engine, ELEC TORQUE DRIVER, ELEC handpiece, and ENDO IT endodontic driver, supplying dental devices at home and abroad. It holds 31 patents, 25 designs, 23 trademarks, completed US FDA certification, and is pursuing CE MDR certification.

Products & technology

  • ELEC ENGINEImplant surgery engine system
  • ELEC TORQUE DRIVERImplant surgery torque driver
  • ELECElectric motor handpiece system
  • ENDO ITEndodontic treatment driver

Regulatory approvals

data.go.kr · openFDA

43 Korean MFDS device approvals · 2002–2025 / 7 US FDA 510(k) · 2017–2025

  • FDAELEC ENGINE (Model: ISE-170L)2025-07-18
    510(k) · SpecialDentalK231562
  • MFDSCleansing tube and catheter2025-03-18
    Product approval · Class 1수신 25-519 호
  • MFDSSurgical drill handpiece, manual2025-01-10
    Product approval · Class 1제신 25-40 호
  • FDADental Handpiece, Wireless Endodontic Handpiece, endoit2023-11-09
    510(k) · TraditionalDentalK232810
  • FDADental Handpiece, Model CA160, CA160L, and CA500L2022-07-29
    510(k) · TraditionalDentalK220577
  • FDAELEC-LED2022-02-07
    510(k) · TraditionalDentalK201191
  • FDAImpla-NX (Model: ISE-270M)2021-05-21
    510(k) · TraditionalDentalK201192
  • MFDSCleansing tube and catheter2020-11-30
    Product approval · Class 1제신 20-1757 호
  • MFDSHandpiece, dental, implant surgery2020-10-07
    Product approval · Class 2수인 20-4663 호
  • FDADental Handpiece2020-08-25
    510(k) · TraditionalDentalK192809
  • MFDSDental engine2020-01-16
    Product approval · Class 2제인 20-4035 호
  • MFDSDental engine2019-08-21
    Product approval · Class 2제인 19-4699 호
Show 38 more
  • MFDSDental drill system handpiece, line-powered2019-08-13
    Product approval · Class 2수인 19-4543 호
  • MFDSDental drill system handpiece, pneumatically-powered2019-08-12
    Product approval · Class 2수인 19-4541 호
  • MFDSDental drill system handpiece, line-powered2019-05-07
    Product approval · Class 2제인 19-4364 호
  • MFDSDental drill system handpiece, line-powered2019-01-09
    Product approval · Class 2제인 19-4017 호
  • MFDSDental drill system handpiece, line-powered2018-11-22
    Product approval · Class 2제인 18-4960 호
  • MFDSDental drill system handpiece, line-powered2018-10-25
    Product approval · Class 2제인 18-4867 호
  • MFDSAbrasive device2017-07-25
    Product approval · Class 1수신 17-2336 호
  • MFDSDental engine, implant surgery2017-05-15
    Product approval · Class 2제인 17-4341 호
  • MFDSDental engine2017-03-31
    Product approval · Class 2제인 17-4241 호
  • FDAMEG-TORQ2017-02-22
    510(k) · TraditionalDentalK161500
  • MFDSDental engine2017-01-31
    Product approval · Class 2제인 17-4063 호
  • MFDSUnit and chair, dentalRevoked2017-01-03
    Product approval · Class 2수인 17-4006 호
  • MFDSDental drill system handpiece, line-powered2016-02-15
    Product approval · Class 2제인 16-4133 호
  • MFDSDental drill system handpiece, line-poweredRevoked2015-12-29
    Product approval · Class 2수인 15-4278 호
  • MFDSHandpiece, dental, implant surgeryRevoked2015-09-23
    Product approval · Class 2수인 15-4091 호
  • MFDSCleansing tube and catheterRevoked2015-09-23
    Product approval · Class 1제신 15-166 호
  • MFDSDental engine2015-06-25
    Product approval · Class 2제인 15-1009 호
  • MFDSimplant, endosseous, screw driverRevoked2015-05-15
    Product approval · Class 1대구 제신 15-39 호
  • MFDSDental engine, implant surgery2015-05-07
    Product approval · Class 2제인 15-694 호
  • MFDSDental engineRevoked2015-01-08
    Product approval · Class 1대구 제신 15-2 호
  • MFDSDental engine, implant surgeryRevoked2014-12-31
    Product approval · Class 2제허 14-3375 호
  • MFDSDental drill system handpiece, line-powered2013-10-10
    Product approval · Class 2제인 13-1713 호
  • MFDSDental drill system handpiece, line-powered2013-07-04
    Product approval · Class 2제인 13-1163 호
  • MFDSLight, dental, general-purpose2013-04-18
    Product approval · Class 1대구 수신 13-21 호
  • MFDSDental drill system handpiece, line-poweredRevoked2012-12-20
    Product approval · Class 2제허 12-1667 호
  • MFDS치과기공용핸드피스Revoked2009-08-21
    Product approval · Class 1대구 제신 09-29 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-15
    Product approval · Class 1대구 제신 07-75 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-71 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-72 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-67 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-69 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-68 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-66 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-70 호
  • MFDS의료용핸드피스(수동식, 치과기공용)Revoked2007-06-11
    Product approval · Class 1대구 제신 07-73 호
  • MFDS의료용핸드피스Revoked2002-05-16
    Product approval · Class 1대구 제신 02-18 호
  • MFDS의료용핸드피스Revoked2002-05-16
    Product approval · Class 1대구 제신 02-19 호
  • MFDS의료용핸드피스Revoked2002-05-16
    Product approval · Class 1대구 제신 02-20 호

R&D and key agreements

Source: DART corporate disclosure

네일용 BLDC 핸드피스 · 시제품 제작완료, 제어기 업그레이드 개선 진행중 · Prototype of a compact BLDC motor handpiece with in-house sensorless control technology

150,000RPM 기공용 핸드피스 슬림화 · 시제품 개발완료, 양산 진행 · Development of a slim 150,000RPM handpiece for zirconia processing, under 22.5mm diameter and 106g

치과 시술용 증속앵글 및 센서리스 엔진 개발 · 시제품 제작완료, CE MDR 인증 진행중 · Development of an electric 1:5 speed-increasing handpiece (200,000RPM) with internal irrigation and a sensorless BLDC motor controller, joint research with Daegu Mechatronics & Materials Institute

토크 드라이버 신규 모델 개발 · New battery-embedded model of existing implant placement and orthodontic torque drivers, with a 16:1 reduction straight angle handpiece completed

Patents

KIPRIS · applicant-matched
Show 24 more patents

AI reads

MAA server logs · IP-verified
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Measured since Aug 27, 2026 · 4 AI engines · last read Oct 10, 2026

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Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

SHINHUNG CO.,LTD14 shared

Founded in 1964 and KOSPI-listed in 1991, Shinhung manufactures and distributes dental equipment and materials.

DIO Corporation6 shared

DIO Corporation, established in 1988 and listed on KOSDAQ in 2000, manufactures and sells dental implants.

YUHAN CORPORATION6 shared

Founded in 1926 and listed on the KOSPI in 1962, Yuhan Corporation is a comprehensive pharmaceutical company known for its innovative drug Leclaza.

CUREXO, INC.3 shared

Develops and sells surgical robots Cuvis-joint/Cuvis-spine and the rehabilitation robot Morning Walk.

CG MedTech Co.,Ltd.3 shared

Founded in 1997 and KOSDAQ-listed in 2015, CG MedTech makes orthopedic medical devices and also operates an electric energy business.

DENTIS CO.,LTD3 shared

Founded in 2016 and listed on KOSDAQ in 2017, DENTIS manufactures dental implants, medical LED lighting, and dental 3D printers.

Corentec Co., Ltd.2 shared

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

JMT CO.,Ltd.2 shared

Provides EMS and SMT manufacturing services for TFT-LCD and OLED panel driver PBAs.

Alpha AI Co.,Ltd.2 shared

Alpha AI, founded in 1995 and KOSDAQ-listed in 2000, manufactures biocompatible metal implants and surgical instruments.

BASKHANBIOPharma Inc.1 shared

Founded 1986, KONEX-listed since 2022, BASKHANBIOPharma makes drugs and medical devices for use before and after surgery.

L&K BIOMED CO., LTD.1 shared

Spinal implant device maker founded 2008, listed on KOSDAQ 2016; produces Cervical and Thoraco Lumbar Cage, Screw, and Plate products.

OSTEONIC Co., Ltd.1 shared

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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