# K133298: Endo Smart

- Pathway: 510(k) (Traditional)
- Applicant: Meta Biomed, Inc.
- Decided: Sep 19, 2014 after 329 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: 4 generations back to K971350 (1997). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111616: E-CUBE, Saeshin Precision Co., Ltd. (2011) Summary page 4.
- K092614: X-Smart Easy, Dentsply Interntional (2009) Summary page 7.

## Cited in the summary but kept off the family tree
- K082167: Portable X-Ray System, Models Diox-602, Prox, Digimed Corporation (2008). Our reading of the summary gave K082167, FDA’s number for Portable X-Ray System, Models Diox-602, Prox (Digimed Corporation). Its FDA name has none of the distinctive words the summary uses for the device it names, “X-Smart Easy”. Kept off the family tree. Summary page 4.

## Most influential descendants
- 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
- K251811: Motor and Apex Module (MaAM) (2025), 0 descendants of its own
- K242317: Integrated Endo System (Meet Endo-II) (2025), 0 descendants of its own

## Indications for use
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills

Source page: https://510kreport.com/device/K133298
Methodology: https://510kreport.com/methodology