Data / Medical devices / South Korea / Micro-Nx Co., Ltd.

Micro-Nx Co., Ltd.: FDA-registered device maker in Dong-gu Daegu, South Korea, 7 510(k) clearances

Name: Micro-Nx Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Micro-Nx Co., Ltd. is registered with the FDA (registration 3007345485) in Dong-gu Daegu, South Korea. It lists 4 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3007345485
Address: 22, Maeyeo-ro 1-gil, Dong-gu Daegu, South Korea, 41059
Owner or operator: MICRO-NX Co., Ltd. (10054332)
Roles: Contract manufacturer, Manufacturer
First device listed: March 8, 2017
Registered through: 2026
Brand names listed: Choice Pro, Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model: EH-C500), Dental Torque Driver for Implant Surgery (Model: MEG-TORQ), Dental Torque Driver for Implant Surgery (Model: OSM-TORQ), Dental Torque Driver for Implant Surgery (Model: TD-C60), ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170), ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170C), ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170L) and more

Devices it lists

Device	Product code	Class	Role	Source
Controller, Foot, Handpiece And Cord	EBW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Handpiece, Belt And/Or Gear Driven, Dental	EFA	1	Manufacturer	accessdata.fda.gov
Handpiece, Contra- And Right-Angle Attachment, Dental	EGS	1	Manufacturer	accessdata.fda.gov
Handpiece, Direct Drive, Ac-Powered	EKX	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 18, 2025	K231562	ELEC ENGINE (Model: ISE-170L)	EBW	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov
November 9, 2023	K232810	Dental Handpiece, Wireless Endodontic Handpiece, endoit	EKX	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov
July 29, 2022	K220577	Dental Handpiece, Model CA160, CA160L, and CA500L	EGS	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov
February 7, 2022	K201191	ELEC-LED	EBW	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov
May 21, 2021	K201192	Impla-NX (Model: ISE-270M)	EBW	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov
August 25, 2020	K192809	Dental Handpiece	EFA	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov
February 22, 2017	K161500	MEG-TORQ	EKX	Substantially Equivalent	Micro-Nx Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated July 18, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.