# K111616: E-CUBE

- Pathway: 510(k) (Traditional)
- Applicant: Saeshin Precision Co., Ltd.
- Decided: Aug 19, 2011 after 70 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
Longest line of descent: 3 generations back to K971350 (1997). 6 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092614: X-Smart Easy, Dentsply Interntional (2009) Summary page 1.
- K092412: Strong Implant Handpieces, Saeshin Precision Co., Ltd. (2009) Summary page 1.

## Most influential descendants
- K133298: Endo Smart (2014), 6 descendants of its own
- K153285: EMS-200 (2016), 5 descendants of its own
- K202906: EndoPilot2 (2021), 4 descendants of its own
- K233865: X-Smart Pro; X-Smart Pro+ (2024), 1 descendant of its own
- K143411: Traus Endo (2015), 1 descendant of its own

## Indications for use
The B-CUBE is indicated for use by dentists in standard endodontic procedures using rotary endodontic files and rotary endodontic drills(Gates-Glidden).

Source page: https://510kreport.com/device/K111616
Methodology: https://510kreport.com/methodology