K Number
K050612
Date Cleared
2005-05-04

(55 days)

Product Code
Regulation Number
872.4200
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

LightSpeed Cordless Endodontic Handpiece

AI/ML Overview

This document is a 510(k) clearance letter for the LightSpeed Cordless Endodontic Handpiece. It does not contain information about acceptance criteria or a study proving the device meets them. The letter confirms substantial equivalence to predicate devices and outlines regulatory responsibilities.

Therefore, I cannot answer your request based on the provided text.

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.