# K111078: Aeu-26L Elctronic Endodontic System

- Pathway: 510(k) (Abbreviated)
- Applicant: Aseptico, Inc.
- Decided: Jun 14, 2011 after 57 days
- Product code: EKX (Handpiece, Direct Drive, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 872.4200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000547 (2000). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030163: Aseptico VCT Versatile Command Technology Model Aeu-925, Aseptico, Inc. (2003) Summary page 2.
- K103399: General Denistry Motor, Aseptico, Inc. (2011) Summary page 2.
- K000547: Atr Tecnika, Advanced Technology Research (A.T.R.) S.R.P. (2000) Summary page 2.

## Most influential descendants
- K123608: Endo E Class (2013), 1 descendant of its own
- K141482: KI-20 (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K111078
Methodology: https://510kreport.com/methodology