510(k) · Cleared
ClearedAseptico VCT Versatile Command Technology Model Aeu-925
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 Mar 3, 2003 after a 46-day review. The FDA summary names no predicate by number. 5 later devices descend from it.
- Decided
- Mar 3, 2003
- Review
- 46 days
- Class
- Class I
- Product code
- EKX
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK030163 Aseptico VCT Versatile Command Technology Model Aeu-925Aseptico, Inc. · 2003
- 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 · cites it directly · 1 of its ownK041279 Implanteo Implantology MotorAnthogyr · 2004
- Descendant · 3 generations on · 0 of its ownK141482 KI-20Saeyang Microtech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK102241 Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011
Most influential descendants
Showing 5 of 5 · See all- K111078Aeu-26L Elctronic Endodontic SystemAseptico, Inc. · 2011 · cites it directly2descendants
- K123608Endo E ClassSaeyang Microtech Co., Ltd. · 2013 · 2 generations on1descendant
- K041279Implanteo Implantology MotorAnthogyr · 2004 · cites it directly1descendant
- K141482KI-20Saeyang Microtech Co., Ltd. · 2015 · 3 generations on0descendants
- K102241Anthogyr Implanteo Implantology and Dental Surgical Motor UnitAnthogyr Sas · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030163 | Aseptico VCT Versatile Command Technology Model Aeu-925 | Aseptico, Inc. | 2003 | — |
| +1 | K111078 | Aeu-26L Elctronic Endodontic System | Aseptico, Inc. | 2011 | — |
| +2 | K123608 | Endo E Class | Saeyang Microtech Co., Ltd. | 2013 | — |
| +1 | K041279 | Implanteo Implantology Motor | Anthogyr | 2004 | — |
| +3 | K141482 | KI-20 | Saeyang Microtech Co., Ltd. | 2015 | — |
| +2 | K102241 | Anthogyr Implanteo Implantology and Dental Surgical Motor Unit | Anthogyr Sas | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2011 | 2 | 0 |
| 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?
The FDA summary names no predicate by number.
What descends from it? (5)
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?
- 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.
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?
Aseptico's AEU-925 VCT can be used for a wide range of dental procedures including;
1) Dental endodontic surgeries, such as drilling into the root canal
2) General dentistry, such as removing carious material from the dentine.
3) Performing dental implant surgeries, such as perforating the bone, and tapping and threading procedures required before placement of implant prosthetics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030163 · printed Nov 4, 2026
Cite this page
510(k) Report. “K030163: Aseptico VCT Versatile Command Technology Model Aeu-925.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K030163
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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