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K Number
K161855
Device Name
LED Curing Light
Manufacturer
MONITEX INDUSTRIAL CO., LTD.
Date Cleared
2017-11-27

(509 days)

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

This "LED Curing Light GT-2000 Carbon" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 360-420 nm and 420-490 nm by dental professionals.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for a dental curing light. It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific details requested in your prompt regarding AI/ML device evaluation.

Therefore, I cannot extract the requested information from this document.

§ 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.