# K050612: Lightspeed Cordless Endodontic Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Lightspeed Technology, Inc.
- Decided: May 4, 2005 after 55 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
This device is for use only by a licensed dentist for the purpose of delivering rotary root canal preparation treatment only. Device may also be used by licensed dental hygienist for polishing outside of teeth after cleaning.

Source page: https://510kreport.com/device/K050612
Methodology: https://510kreport.com/methodology