510(k) · Cleared
ClearedTri Auto Mini - Endodeontic Treatment Motorized Handpiece
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 May 4, 2012 as substantially equivalent to K921979 (J. Morita USA, Inc., 1993) and 3 other predicates after a 234-day review. Its family tree reaches back 6 generations to 1995. 1 later device descends from it.
- Decided
- May 4, 2012
- Review
- 234 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K951425 (1995). 13 ancestors in all, the oldest K921979 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK951425 Spectrum Curing Light Polymerization UnitDentsply Intl. · 1995
- 5 generations backK982318 Spectrum 800 Curing UnitDentsply Intl. · 1998
- 4 generations backK031615 Sled Curing Light SystemDentsply International · 2003
- 3 generations backK041372 Smartlite PS Pen-Style Led Curing LightDentsply International · 2004
- 2 generations backK063529 Pencure, Model VL-7J. Morita USA, Inc. · 2007
- 1 generation backK071190 Root ZX IIJ. Morita USA, Inc. · 2007
- This deviceK112665 Tri Auto Mini - Endodeontic Treatment Motorized HandpieceJ. Morita USA, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK210475 EQ-MMeta Systems Co., Ltd. · 2022
Most influential descendants
Showing 1 of 1 · See all- K210475EQ-MMeta Systems Co., Ltd. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K951425 | Spectrum Curing Light Polymerization Unit | Dentsply Intl. | 1995 | — |
| −5 | K982318 | Spectrum 800 Curing Unit | Dentsply Intl. | 1998 | — |
| −4 | K031615 | Sled Curing Light System | Dentsply International | 2003 | — |
| −3 | K041372 | Smartlite PS Pen-Style Led Curing Light | Dentsply International | 2004 | — |
| −2 | K063529 | Pencure, Model VL-7 | J. Morita USA, Inc. | 2007 | — |
| −1 | K071190 | Root ZX II | J. Morita USA, Inc. | 2007 | — |
| 0 (this device) | K112665 | Tri Auto Mini - Endodeontic Treatment Motorized Handpiece | J. Morita USA, Inc. | 2012 | — |
| +1 | K210475 | EQ-M | Meta Systems Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K921979 | Root ZXSummary page 2…ri Auto mini indicates the position of the file tip inside the root canal. SUBSTANTIAL EOUIVALENCE The Tri Auto mini is substantially equivalent to Tri Auto ZX (K(921979/ K953867) and ROOT ZX 11 (K071190). 1) Predicate device I : Tni Auto ZX (K(921979/Y(953867) The Tri Auto mini is substantial… | 1993 |
| * | K953867 | Root Canal Length Measuring DeviceSummary page 2…ini indicates the position of the file tip inside the root canal. SUBSTANTIAL EOUIVALENCE The Tri Auto mini is substantially equivalent to Tri Auto ZX (K(921979/ K953867) and ROOT ZX 11 (K071190). 1) Predicate device I : Tni Auto ZX (K(921979/Y(953867) The Tri Auto mini is substantially equival… | 1995 |
| * | K970339 | Tri Auto ZXSummary page 3…Predicate devices TECHNOLOGICAL Tri Auto ZX ROOT ZX I1 CHARACTERISTICS of (K970339) (K071190) Tri Auto mini Indication for use Identical Identical Canal Enlargem… | 1997 |
| * | K071190 | Root ZX IISummary page 2…n of the file tip inside the root canal. SUBSTANTIAL EOUIVALENCE The Tri Auto mini is substantially equivalent to Tri Auto ZX (K(921979/ K953867) and ROOT ZX 11 (K071190). 1) Predicate device I : Tni Auto ZX (K(921979/Y(953867) The Tri Auto mini is substantially equivalent to 'ri Auto ZX from J… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210475 | EQ-M | 2022 | 0 |
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 17 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K210475 (Meta Systems Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K921979.
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. 2012, 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 mini motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points, and for professional tooth cleaning.
When connected to Apex locator, the Tri Auto mini can be used to measure the length of root canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112665 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112665: Tri Auto Mini - Endodeontic Treatment Motorized Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112665
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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