# K103399: General Denistry Motor

- Pathway: 510(k) (Traditional)
- Applicant: Aseptico, Inc.
- Decided: Feb 28, 2011 after 101 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K111078: Aeu-26L Elctronic Endodontic System (2011), 2 descendants of its own
- K123608: Endo E Class (2013), 1 descendant of its own
- K141482: KI-20 (2015), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K103399
Methodology: https://510kreport.com/methodology