# K123608: Endo E Class

- Pathway: 510(k) (Traditional)
- Applicant: Saeyang Microtech Co., Ltd.
- Decided: Aug 16, 2013 after 268 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: 4 generations back to K970339 (1997). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111078: Aeu-26L Elctronic Endodontic System, Aseptico, Inc. (2011) Summary page 2.
- K042822: TCM Endo V, Model 1534, Nouvag AG (2004) Summary page 1.
- K000547: Atr Tecnika, Advanced Technology Research (A.T.R.) S.R.P. (2000) Summary page 1.

## Most influential descendants
- 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/K123608
Methodology: https://510kreport.com/methodology