510(k) · Cleared
ClearedAlpha Endo Handpiece (Alpha Endo)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Superline Technology CO., LTD. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Oct 16, 2025 as substantially equivalent to K220829 (Foshan Coxo Medical Instrument Co., Ltd., 2023) after a 92-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Oct 16, 2025
- Review
- 92 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K970339 (1997). No later device cites it as a predicate yet.
- Root · 4 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 3 generations backK170275 Tri Auto ZX2J. Morita USA, Inc. · 2017
- 2 generations backK201993 E-connect S Endo Motor with built-in Apex LocatorChangzhou Sifary Medical Technology Co., Ltd. · 2021
- 1 generation backK220829 Endo MotorFoshan Coxo Medical Instrument Co., Ltd. · 2023
- This deviceK252223 Alpha Endo Handpiece (Alpha Endo)Shenzhen Superline Technology CO., LTD. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −3 | K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | 2017 | — |
| −2 | K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | 2021 | — |
| −1 | K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
| 0 (this device) | K252223 | Alpha Endo Handpiece (Alpha Endo) | Shenzhen Superline Technology CO., LTD. | 2025 | — |
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? (1)
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 |
|---|---|---|---|
| * | K220829 | Endo MotorSummary page 5…872.4200 Product Code(s) EKX I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K220829 Endo Motor EKX Device Description Summary 21 CFR 807.92(a)(4) The Alpha Endo Handpiece is a medical electrical device that provi… | 2023 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.4 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K220829.
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. 2025, 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?
Alpha Endo Handpiece is a cordless motor handpiece with torque control used for driving files in both reciprocating and rotation mode during the preparation stage of root canal therapy.
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/K252223 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252223: Alpha Endo Handpiece (Alpha Endo).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252223
Report an extraction error
Are you the manufacturer?
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