# K150129: Aeu-7000L-70V Implant/Endodontic Dental System (Lighted Version)

- Pathway: 510(k) (Traditional)
- Applicant: Aseptico, Inc.
- Decided: May 28, 2015 after 127 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.

Source page: https://510kreport.com/device/K150129
Methodology: https://510kreport.com/methodology