510(k) · Cleared
ClearedDental Handpiece, Wireless Endodontic Handpiece, endoit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Nx Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Nov 9, 2023 as substantially equivalent to K220577 (Micro-Nx Co., Ltd., 2022) and 1 other predicate after a 58-day review. Its family tree reaches back 5 generations to 1997.
- Decided
- Nov 9, 2023
- Review
- 58 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K971350 (1997). 14 ancestors in all, the oldest K970339 (1997). No later device cites it as a predicate yet.
- Root · 5 generations backK971350 Series XE, Series SE, Series TEMicro-Mega Societe Anonyme · 1997
- 4 generations backK040674 Implantology Contra Angles, Endodontic Contra Angles, General…Anthogyr · 2004
- 3 generations backK093894 Anthogyr Impulsion Implantology Contra-AngleAnthogyr · 2010
- 2 generations backK192809 Dental HandpieceMicro-Nx Co., Ltd. · 2020
- 1 generation backK220577 Dental Handpiece, Model CA160, CA160L, and CA500LMicro-Nx Co., Ltd. · 2022
- This deviceK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K971350 | Series XE, Series SE, Series TE | Micro-Mega Societe Anonyme | 1997 | — |
| −4 | K040674 | Implantology Contra Angles, Endodontic Contra Angles, General Dentistry Contra… | Anthogyr | 2004 | — |
| −3 | K093894 | Anthogyr Impulsion Implantology Contra-Angle | Anthogyr | 2010 | — |
| −2 | K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | 2020 | — |
| −1 | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | 2022 | — |
| 0 (this device) | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EKX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EKX device
- #1 K261987 Reusable SmartPegscore 13.2 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LSummary page 5…Class: Class I • Traditional 510(k) Registration Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece (K220577) Model CA160, CA160L, and CA500L Ⅲ. PREDICATE DEVICES • Dental Handpiece model CA160L (K220577), Manufacturer: Micro-NX Co… | 2022 |
| * | K123582 | Endo a ClassSummary page 5…ce (K220577) Model CA160, CA160L, and CA500L Ⅲ. PREDICATE DEVICES • Dental Handpiece model CA160L (K220577), Manufacturer: Micro-NX Co., Ltd. • Endo A Class (K123582), Manufacturer: Saeyang Microtech Co., Ltd. 1 Ⅳ. DEVICE DESCRIP… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All EKX devicesEKX Handpiece, Direct Drive, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · EKX
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EKX
244in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EKX
No recall names EKX since 2007.
Adverse event reports per year · EKX
9in 2025
MAUDE reports naming product code EKX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 9 |
| 2008 | 3 | 101 | 0 | 10 |
| 2009 | 4 | 186 | 0 | 11 |
| 2010 | 3 | 114 | 0 | 20 |
| 2011 | 4 | 75 | 0 | 6 |
| 2012 | 2 | — | 0 | 27 |
| 2013 | 2 | — | 0 | 45 |
| 2014 | 3 | 251 | 0 | 102 |
| 2015 | 3 | 178 | 0 | 68 |
| 2016 | 3 | 274 | 0 | 66 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 3 | 293 | 0 | 49 |
| 2019 | 3 | 349 | 0 | 56 |
| 2020 | 1 | — | 0 | 67 |
| 2021 | 5 | 214 | 0 | 79 |
| 2022 | 3 | 359 | 0 | 37 |
| 2023 | 4 | 152 | 0 | 14 |
| 2024 | 4 | 276 | 0 | 19 |
| 2025 | 5 | 244 | 0 | 9 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232810
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026