# K111623: I-Endo Dual

- Pathway: 510(k) (Traditional)
- Applicant: Satelec - Acteon Group
- Decided: Jan 10, 2012 after 214 days
- Product code: EBW (Controller, Foot, Handpiece And Cord)
- 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: 3 generations back to K990682 (1999). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103653: E3 Torque Control Motor, Dentsply International, Inc. (2011) Summary page 2.

## Most influential descendants
- K131151: Endocenter (2014), 0 descendants of its own

## Indications for use
I-Endo Dual is indicated for use by dentists in standard endodontic procedures using endodontic files and endodontic drills.

Source page: https://510kreport.com/device/K111623
Methodology: https://510kreport.com/methodology