# K092614: X-Smart Easy

- Pathway: 510(k) (Traditional)
- Applicant: Dentsply Interntional
- Decided: Dec 2, 2009 after 98 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: 1 generation back to K990682 (1999). 1 ancestor in all.
20 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990682: Prophy-Mate Motor Handpiece, Models Prophy-Mate (2000 RPM Max), Endo-Mate (600RPM Max.), Nsk Nakanishi, Inc. (1999) Summary page 1.

## Most influential descendants
- K111616: E-CUBE (2011), 10 descendants of its own
- K103653: E3 Torque Control Motor (2011), 8 descendants of its own
- 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

## Indications for use
X-Srnart Easy is indicated for use by dentists in standard endodontic procedures using rotary endodonftic files and rotary endodontic drills (Gates-Glidden).

Source page: https://510kreport.com/device/K092614
Methodology: https://510kreport.com/methodology