510(k) · Cleared
ClearedTri Auto ZX
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 Jun 4, 1997 after a 126-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 283 later devices descend from it.
- Decided
- Jun 4, 1997
- Review
- 126 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 0
283 later devices descend from it, 7 citing it directly.
- This deviceK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- Descendant · cites it directly · 246 of its ownK012511 Waterlase MillenniumBiolase Technology, Inc. · 2002
- Descendant · 2 generations on · 240 of its ownK021508 Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002
- Descendant · 3 generations on · 226 of its ownK040270 Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004
- Descendant · 4 generations on · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 5 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
Showing 5 of 283 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 283 · See all- K012511Waterlase MillenniumBiolase Technology, Inc. · 2002 · cites it directly246descendants
- K021508Opusduo EC Dental Laser SystemOpusdent, Ltd. · 2002 · 2 generations on240descendants
- K040270Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus SpectrumLumenis, Ltd. · 2004 · 3 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · 4 generations on221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 5 generations on202descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| +1 | K012511 | Waterlase Millennium | Biolase Technology, Inc. | 2002 | — |
| +2 | K021508 | Opusduo EC Dental Laser System | Opusdent, Ltd. | 2002 | — |
| +3 | K040270 | Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum | Lumenis, Ltd. | 2004 | — |
| +4 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +5 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 12 | 0 |
| 2009 | 7 | 0 |
| 2010 | 11 | 0 |
| 2011 | 7 | 0 |
| 2012 | 6 | 0 |
| 2013 | 12 | 0 |
| 2014 | 11 | 0 |
| 2015 | 15 | 0 |
| 2016 | 11 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 7 | 0 |
| 2020 | 15 | 0 |
| 2021 | 13 | 0 |
| 2022 | 27 | 0 |
| 2023 | 17 | 0 |
| 2024 | 24 | 0 |
| 2025 | 32 | 0 |
| 2026 | 16 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (283)
See all 2837 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012511 | Waterlase Millennium | 2002 | 246 |
| K022147 | Denta Port | 2002 | 16 |
| K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor | 2009 | 11 |
| K170275 | Tri Auto ZX2 | 2017 | 8 |
| K092833 | Endomax Cordless Endodontic Handpiece | 2010 | 4 |
| K123582 | Endo a Class | 2013 | 3 |
| K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | 2012 | 1 |
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?
- Of its descendants, K012511 (Biolase Technology, Inc., 2002) has gone furthest, with 246 descendants of its own.
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.
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 ZX 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 to measure the length of the canal,
and it can be used as a low speed motorized handpiece.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K970339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970339: Tri Auto ZX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970339
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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