# K170275: Tri Auto ZX2

- Pathway: 510(k) (Traditional)
- Applicant: J. Morita USA, Inc.
- Decided: Sep 11, 2017 after 224 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 K970339 (1997). 1 ancestor in all.
8 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970339: Tri Auto ZX, J. Morita USA, Inc. (1997) Summary page 7.

## Most influential descendants
- K201993: E-connect S Endo Motor with built-in Apex Locator (2021), 4 descendants of its own
- K220829: Endo Motor (2023), 2 descendants of its own
- K203320: Endo Motor (2021), 1 descendant of its own
- K252223: Alpha Endo Handpiece (Alpha Endo) (2025), 0 descendants of its own
- K243692: EnDrive (EnDriveUS) (2025), 0 descendants of its own

## Indications for use
The Tri Auto ZX2 device is a cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

Source page: https://510kreport.com/device/K170275
Methodology: https://510kreport.com/methodology