510(k) · Cleared
ClearedAeu-26L Elctronic Endodontic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aseptico, Inc. · EKX Handpiece, Direct Drive, Ac-Powered
Cleared on Jun 14, 2011 as substantially equivalent to K030163 (Aseptico, Inc., 2003) and 2 other predicates after a 57-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jun 14, 2011
- Review
- 57 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K000547 (2000). 3 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000547 Atr TecnikaAdvanced Technology Research (A.T.R.) S.R.P. · 2000
- This deviceK111078 Aeu-26L Elctronic Endodontic SystemAseptico, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK123608 Endo E ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · 2 generations on · 0 of its ownK141482 KI-20Saeyang Microtech Co., Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000547 | Atr Tecnika | Advanced Technology Research (A.T.R.) S.R.P. | 2000 | — |
| 0 (this device) | K111078 | Aeu-26L Elctronic Endodontic System | Aseptico, Inc. | 2011 | — |
| +1 | K123608 | Endo E Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +2 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K030163 | Aseptico VCT Versatile Command Technology Model Aeu-925Summary page 2…but two of the features listed above "Technological Characteristics" for the AEU-26L are already part of Aseptico's model AEU-925, which was cleared under 510(k) number K030163. Both models can be used for endodontic surgery. **Allows attachment of lighted handpieces The AEU-26L allows use of contra angle… | 2003 |
| * | K103399 | General Denistry MotorSummary page 2…e illumination from the Light Emitting Diode (LED) of the AE-250L motor. This technology is substantially equivalent to the Aseptic AEU-5000 cleared under 51 0(k) number K1 03399. **Reciprocating drive Reciprocating drive is a forward and reverse cycle that can be selected as an alternate motion to simply d… | 2011 |
| * | K000547 | Atr TecnikaSummary page 2…y driving forward or reverse. Bench testing of the AEU-26L establishes that the AEU- 26L provides the same type of reciprocation as the ATR TECNIKA device, cleared under K000547. **Technological characteristics from predicate devices other than Aseptico's Model AEU-925… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123608 | Endo E Class | 2013 | 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?
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. 2011, 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?
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111078 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111078: Aeu-26L Elctronic Endodontic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111078
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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