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510(k) Data Aggregation
K Number
K161855Device Name
LED Curing Light
Manufacturer
Date Cleared
2017-11-27
(509 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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
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K Number
K152192Device Name
LED Curing Light
Manufacturer
Date Cleared
2017-04-07
(611 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
LED Curing Light LD-M4 . LD-M4P is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 420-490 nm by dental professionals.
Device Description
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K Number
K153078Device Name
LED Curing Light GT-2000
Manufacturer
Date Cleared
2016-06-28
(249 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This "LED Curing Light GT-2000" 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
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K Number
K150205Device Name
LED Curing Light
Manufacturer
Date Cleared
2015-08-24
(207 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
BlueLEX LED Curing Light LD-109 is for the polymerization of light cure materials.
Device Description
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K Number
K133040Device Name
LED CURING LIGHT
Manufacturer
Date Cleared
2014-10-07
(377 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This" LED Curing Light LD-M1" is for the polymerization of light cure materials.
Device Description
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K Number
K091887Device Name
LED CURING LIGHT, MODEL GT-1500
Manufacturer
Date Cleared
2009-09-18
(86 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This" LED Curing Light GT-1500" is for the polymerization of light cure materials.
Device Description
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K Number
K080035Device Name
LED CURING LIGHT
Manufacturer
Date Cleared
2008-03-03
(56 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This" LED Curing Light GT-1200" is for the polymerization of light cure materials.
Device Description
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K Number
K060646Device Name
BLUE LUXCER CURING LIGHT, MODELS M-830, M-835 AND M-855
Manufacturer
Date Cleared
2006-04-21
(42 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This Blue Luxcer, Curing Light is a visible curing unit programmed for polymerization of light cured materials by dental professionals.
Device Description
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K Number
K051203Device Name
BLUELEX
Manufacturer
Date Cleared
2005-05-25
(14 days)
Product Code
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
MONITEX INDUSTRIAL CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The intended use of the BlueLEX LD-105 is for the polymerization of light cure materials.
Device Description
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