510(k) · Cleared
ClearedEndo a Class
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saeyang Microtech Co., Ltd. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Aug 16, 2013 as substantially equivalent to K092833 (Dentamerica, 2010) and 2 other predicates after a 269-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Aug 16, 2013
- Review
- 269 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K970339 (1997). 4 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK970339 Tri Auto ZXJ. Morita USA, Inc. · 1997
- 1 generation backK090931 Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorW&H Dentalwerk Buermoos GmbH · 2009
- This deviceK123582 Endo a ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · cites it directly · 1 of its ownK143411 Traus EndoSaeshin Precision Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK232810 Dental Handpiece, Wireless Endodontic Handpiece, endoitMicro-Nx Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK212043 Traus EndoSaeshin Precision Co., Ltd. · 2022
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K970339 | Tri Auto ZX | J. Morita USA, Inc. | 1997 | — |
| −1 | K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo Motor | W&H Dentalwerk Buermoos GmbH | 2009 | — |
| 0 (this device) | K123582 | Endo a Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +1 | K143411 | Traus Endo | Saeshin Precision Co., Ltd. | 2015 | — |
| +1 | K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023 | — |
| +2 | K212043 | Traus Endo | Saeshin Precision Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K092833 | Endomax Cordless Endodontic HandpieceSummary page 1…been placed: The Dental panel has classified this device as Class 1,21 CFIR Part 872.4200, Product Code EKX 3. Predicate Device Information: 1. K092833 Dentamerica Inc Cordless Endodontic Handpiece 2, K970339 J. Morita USA, Inc Tri Auto Zx 3. 090931 W… | 2010 |
| * | K970339 | Tri Auto ZXSummary page 1…e as Class 1,21 CFIR Part 872.4200, Product Code EKX 3. Predicate Device Information: 1. K092833 Dentamerica Inc Cordless Endodontic Handpiece 2, K970339 J. Morita USA, Inc Tri Auto Zx 3. 090931 W & H Dentaiwerk GMBH Cordless ENDO handpiece ENTRAN 4. D… | 1997 |
| * | K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorSummary page 2…_ ___ Device Predicate I Predicate 2 Predicate 3 510(k) Number K092833 K970339 K090931 ENTRAN & 5 Device Name ENDO a Glass Endo-… | 2009 |
What descends from it? (3)
2 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?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K143411 (Saeshin Precision Co., Ltd., 2015) has gone furthest, with 1 descendant 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. 2013, 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?
This application area extends to endlodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123582 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123582: Endo a Class.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123582
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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