# K092833: Endomax Cordless Endodontic Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Dentamerica
- Decided: Jan 7, 2010 after 114 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). 2 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 7 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.
- K970339: Tri Auto ZX, J. Morita USA, Inc. (1997) Summary page 1.

## Most influential descendants
- K123582: Endo a Class (2013), 3 descendants of its own
- K143411: Traus Endo (2015), 1 descendant of its own
- K232810: Dental Handpiece, Wireless Endodontic Handpiece, endoit (2023), 0 descendants of its own
- K212043: Traus Endo (2022), 0 descendants of its own

## Indications for use
The EndomaX is a cordless handpiece used primarily for root canal enlargement. This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.

Source page: https://510kreport.com/device/K092833
Methodology: https://510kreport.com/methodology