Manufacturer registered with FDA
MICRO-NX Co., Ltd.
Daegu, South Korea. Lists 4 dental device types with FDA across 1 registered establishment, and holds 7 510(k) clearances as applicant.
- Device types listed
- 4
- Brands and models
- 25
- 510(k) clearances
- 72017–2025
- Markets registered in
- 955 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name MICRO-NX Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | MICRO-NX Co., Ltd. | 7 clearances | 2017–2025 | Below |
| European Union | EUDAMED | Manufacturer | MICRO-NX Co., Ltd. | 26 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MICRO-NX CO., LTD.MICRO-NX Co., Ltd. · MICRONX CO., LTD · +1 | 11 | 2012–2023 | Pure Global AI |
| Australia | TGA | Manufacturer | MICRO-NX Co LtdMicro NX Co Ltd | 4 | 2018–2023 | Pure Global AI |
| China | NMPA | Registration holder | 麦科乐医疗器械有限公司MICRO-NX CO., Ltd.麦科乐医疗器械有限公司MICRO-NX Co., Ltd. · 麦科乐医疗器械有限公司MicroNX Co., Ltd. | 3 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | MICRO-NX Co; Ltd. | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | MICRO-NX Co., Ltd.Micro-NX Co., Ltd | 3 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Micro-NX Co.,Ltd | 3 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Micro-NX Co. Ltd | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What MICRO-NX Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Handpiece and Cord Foot ControllerEBW · Class 1 | — | Maker | Choice ProELEC 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)ELEC-LED, Electric Micromotor for Dental Handpiece (Model: EL-B40I)ELEC-LED, Electric Micromotor for Dental Handpiece (Model: EL-B40L)ELEC-LED, Electric Micromotor for Dental Handpiece (Model: EL-B40M)ELEC-LED, Electric Micromotor for Dental Handpiece (Model: EL-B40S)Impla-NX, ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-270C)Impla-NX, ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-270M) 2 moreMedilectricThor 700+ | 2021 |
| Ac-Powered Direct Drive HandpieceEKX · Class 1 | Dental handpieces | Maker | 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) | 2017 |
| Dental Belt and/or Gear Driven HandpieceEFA · Class 1 | Dental handpieces | Maker | ELEC, Dental Handpiece (Model: CA100L)ELEC, Dental Handpiece (Model: CA100R)ELEC, Dental Handpiece (Model: SA100L)ELEC, Dental Handpiece (Model: SA100R)ELEC, Dental Handpiece (Model: SG200)ELEC, Dental Handpiece (Model: SG200L) | 2020 |
| Dental Contra- and Right-Angle Attachment HandpieceEGS · Class 1 | Dental handpieces | Maker | ELEC, Dental Handpiece (Model: CA160)ELEC, Dental Handpiece (Model: CA160L)ELEC, Dental Handpiece (Model: CA500L) | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names MICRO-NX Co., Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Jul 2025 | K231562 | ELEC ENGINE (Model: ISE-170L) | EBW Handpiece and Cord Foot Controller |
| 9 Nov 2023 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | EKX Ac-Powered Direct Drive Handpiece |
| 29 Jul 2022 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | EGS Dental Contra- and Right-Angle Attachment Handpiece |
| 7 Feb 2022 | K201191 | ELEC-LED | EBW Handpiece and Cord Foot Controller |
| 21 May 2021 | K201192 | Impla-NX (Model: ISE-270M) | EBW Handpiece and Cord Foot Controller |
| 25 Aug 2020 | K192809 | Dental Handpiece | EFA Dental Belt and/or Gear Driven Handpiece |
| 22 Feb 2017 | K161500 | MEG-TORQ | EKX Ac-Powered Direct Drive Handpiece |
Some of these clearances are listed with FDA today by another company: Well Medical (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MICRO-NX CO., LTD.FDA reg. 3007345485 | Dong-gu Daegu, South Korea | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054332). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.