# K141482: KI-20

- Pathway: 510(k) (Traditional)
- Applicant: Saeyang Microtech Co., Ltd.
- Decided: Apr 24, 2015 after 324 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: 5 generations back to K970339 (1997). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123608: Endo E Class, Saeyang Microtech Co., Ltd. (2013) Summary page 4.
- K123695: Traus SIP10, Saeshin Precision Co., Ltd. (2012) Summary page 4.
- K092758: X-CUBE, Saeshin Precision Co., Ltd. (2009) Summary page 4.

## Indications for use
For use in a wide range of dental procedures including: endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.

Source page: https://510kreport.com/device/K141482
Methodology: https://510kreport.com/methodology