Micro-Nx Co., Ltd.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Micro-Nx Co., Ltd.” (first 2017, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 329 days. Since 2017 the median was 329 days, against 262 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 266 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 329 |
| 2021 | 1 | 382 |
| 2022 | 2 | 398 |
| 2023 | 1 | 58 |
| 2024 | 0 | — |
| 2025 | 1 | 779 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Micro-Nx Co., Ltd. took a median 329 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 262 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBW | Controller, Foot, Handpiece And Cord | 3 | 3 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 | 2 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 1 | 1 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 1 | 1 |
Review panels
- Dental (7)
Most recent Micro-Nx Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231562 | ELEC ENGINE (Model: ISE-170L) | EBW | 2025-07-18 | 779 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | EKX | 2023-11-09 | 58 |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | EGS | 2022-07-29 | 151 |
| K201191 | ELEC-LED | EBW | 2022-02-07 | 644 |
| K201192 | Impla-NX (Model: ISE-270M) | EBW | 2021-05-21 | 382 |
| K192809 | Dental Handpiece | EFA | 2020-08-25 | 329 |
| K161500 | MEG-TORQ | EKX | 2017-02-22 | 266 |
Recalls
openFDA lists no recalls under a recalling firm named Micro-Nx Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Micro-Nx Co., Ltd.?
FDA lists 7 510(k) clearances under the applicant name “Micro-Nx Co., Ltd.” (first 2017, latest 2025), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micro-Nx Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micro-Nx Co., Ltd. is 329 days. Since 2017: 329 days, versus 262 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Micro-Nx Co., Ltd.?
The most frequent FDA product codes under this applicant name are EBW (Controller, Foot, Handpiece And Cord, 3); EKX (Handpiece, Direct Drive, Ac-Powered, 2); EFA (Handpiece, Belt And/Or Gear Driven, Dental, 1).
Next steps
- See all 7 Micro-Nx Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code EBW, Micro-Nx Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.