# K153285: EMS-200

- Pathway: 510(k) (Traditional)
- Applicant: Meta Systems Co., Ltd.
- Decided: Aug 12, 2016 after 274 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: 5 generations back to K971350 (1997). 8 ancestors in all.
5 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)
- K133298: Endo Smart, Meta Biomed, Inc. (2014) Summary page 4.

## Most influential descendants
- 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
- K213947: Ultrasonic Endo Activation Device (Model:Actor I pro) (2022), 0 descendants of its own

## Indications for use
The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.

Source page: https://510kreport.com/device/K153285
Methodology: https://510kreport.com/methodology