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K Number
K040956
Device Name
HILUX LEDMAX 3
Manufacturer
FIRST MEDICAL INFECTION CONTROL ASSOCIATES, INC.
Date Cleared
2004-06-14

(62 days)

Product Code
EBZ
Regulation Number
872.6070
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This curing light is used to cure or set camphorquinone initiated materials used in the dental industry including composites, sealants and cements.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a dental curing light, the Hilux LEDMAX-3. It does not contain a study or detailed acceptance criteria for the device's performance. Instead, it states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information, as it is not present in the provided text. The document is an administrative clearance, not a technical performance report or study.

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.