510(k) Report

FDA applicant

Micro-Nx Co., Ltd.

Daegu, KR7 decisions2017–20250 recalls

FDA records 7 decisions for Micro-Nx Co., Ltd. (Daegu, KR) from 2017 to 2025: 7 510(k) clearances. Most are in product codes EBW (Controller, Foot, Handpiece And Cord) and EKX (Handpiece, Direct Drive, Ac-Powered). Since 2016 its 510(k)s took a median of 398 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Micro-Nx Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017: 12020: 12021: 12022: 22023: 12025: 1
2017high 2 (2022) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Micro-Nx Co., Ltd. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • EBWController, Foot, Handpiece And Cord3decisions
  • EKXHandpiece, Direct Drive, Ac-Powered2decisions
  • EFAHandpiece, Belt And/Or Gear Driven, Dental1decision
  • EGSHandpiece, Contra- And Right-Angle Attachment, Dental1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 398 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 205 days; 2 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 9 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201192Impla-NX (Model: ISE-270M)Micro-Nx Co., Ltd. · 20211cites it
  • K201191Elec-LedMicro-Nx Co., Ltd. · 20221cites it
  • K192809Dental HandpieceMicro-Nx Co., Ltd. · 20201cites it
  • K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 20221cites it

What has FDA decided for it lately?

  • K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd. · 2025
  • K232810Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
  • K220577Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
  • K201191Elec-LedMicro-Nx Co., Ltd. · 2022
  • K201192Impla-NX (Model: ISE-270M)Micro-Nx Co., Ltd. · 2021
  • K192809Dental HandpieceMicro-Nx Co., Ltd. · 2020
  • K161500Meg-TorqMicro-Nx Co., Ltd. · 2017

All 7 as Micro-Nx Co., Ltd. →