510(k) · Cleared
ClearedTri Auto ZX2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J. Morita USA, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Sep 11, 2017 as substantially equivalent to K970339 (J. Morita USA, Inc., 1997) after a 224-day review. Its family tree reaches back 1 generation to 1997. 8 later devices descend from it.
- Decided
- Sep 11, 2017
- Review
- 224 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K970339 (1997). 8 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- This deviceK170275 Tri Auto ZX2J. Morita USA, Inc. · 2017
- Descendant · cites it directly · 4 of its ownK201993 E-connect S Endo Motor with built-in Apex LocatorChangzhou Sifary Medical Technology Co., Ltd. · 2021
- Descendant · 2 generations on · 2 of its ownK220829 Endo MotorFoshan Coxo Medical Instrument Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK203320 Endo MotorGuilin Woodpecker Medical Instrument Co., Ltd. · 2021
- Descendant · 3 generations on · 0 of its ownK252223 Alpha Endo Handpiece (Alpha Endo)Shenzhen Superline Technology CO., LTD. · 2025
- Descendant · 3 generations on · 0 of its ownK243692 EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K201993E-connect S Endo Motor with built-in Apex LocatorChangzhou Sifary Medical Technology Co., Ltd. · 2021 · cites it directly4descendants
- K220829Endo MotorFoshan Coxo Medical Instrument Co., Ltd. · 2023 · 2 generations on2descendants
- K203320Endo MotorGuilin Woodpecker Medical Instrument Co., Ltd. · 2021 · cites it directly1descendant
- K252223Alpha Endo Handpiece (Alpha Endo)Shenzhen Superline Technology CO., LTD. · 2025 · 3 generations on0descendants
- K243692EnDrive (EnDriveUS)Advanced Technology Research (A.T.R.) S.R.L. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| 0 (this device) | K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | 2017 | — |
| +1 | K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | 2021 | — |
| +2 | K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023 | — |
| +1 | K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | 2021 | — |
| +3 | K252223 | Alpha Endo Handpiece (Alpha Endo) | Shenzhen Superline Technology CO., LTD. | 2025 | — |
| +3 | K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 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? (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 |
|---|---|---|---|
| * | K970339 | Tri Auto ZXSummary page 7…- 510(k) Number K970339 K112665 - Canal enlargement - Canal enlargement - Canal enlarg… | 1997 |
| † | K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | 2012 |
| † | K031204 | Dentaport ZX | 2003 |
| † | K953867 | Root Canal Length Measuring Device | 1995 |
| † | K921979 | Root ZX | 1993 |
| † | K090925 | Multiple (Apex Locator), Model RCM-7 | 2009 |
What descends from it? (8)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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. 2017, 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 Tri Auto ZX2 device is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
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/K170275 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170275: Tri Auto ZX2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170275
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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