510(k) · Cleared
ClearedGeneral Denistry Motor
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 Feb 28, 2011 after a 101-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Feb 28, 2011
- Review
- 101 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK103399 General Denistry MotorAseptico, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK111078 Aeu-26L Elctronic Endodontic SystemAseptico, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK123608 Endo E ClassSaeyang Microtech Co., Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK141482 KI-20Saeyang Microtech Co., Ltd. · 2015
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 |
|---|---|---|---|---|---|
| 0 (this device) | K103399 | General Denistry Motor | Aseptico, Inc. | 2011 | — |
| +1 | K111078 | Aeu-26L Elctronic Endodontic System | Aseptico, Inc. | 2011 | — |
| +2 | K123608 | Endo E Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +3 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 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? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111078 | Aeu-26L Elctronic Endodontic System | 2011 | 2 |
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, K111078 (Aseptico, Inc., 2011) has gone furthest, with 2 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. 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?
Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K103399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103399: General Denistry Motor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103399
Report an extraction error
Are you the manufacturer?
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