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K Number
K051203
Device Name
BLUELEX
Manufacturer
MONITEX INDUSTRIAL CO., LTD.
Date Cleared
2005-05-25

(14 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

The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for a dental device, the BlueLEX LD-105 Ultraviolet Activator for Polymerization. It does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested information based on the input.

§ 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.