This page lists all FDA 510(k) submissions for Handpiece, Direct Drive, Ac-powered devices (product code EKX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Dental FDA review panel. Browse all Dental devices →

Data Source

FDA 510(k) public files . 4,872 total devices indexed.

Latest clearance: Mar 21, 2025

Product Code Info

Code	EKX
Device class	Class I
CFR	21 CFR 872.4200
Panel	Dental

Verify on FDA.gov

View EKX classification on FDA.gov →