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510(k) Data Aggregation
K Number
K163605Device Name
LEDEX WL070+
Manufacturer
DENTMATE TECHNOLOGY CO., LTD.
Date Cleared
2017-01-19
(29 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTMATE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LEDEX WL-070+ is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Device Description
Not Found
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K Number
K131042Device Name
LEDEX
Manufacturer
DENTMATE TECHNOLOGY CO., LTD.
Date Cleared
2013-10-03
(171 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTMATE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LEDEX (Family model: WL-090, WL-090+) is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Device Description
Not Found
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K Number
K082408Device Name
LEDEX, MODEL: WL-070
Manufacturer
DENTMATE TECHNOLOGY CO., LTD.
Date Cleared
2008-12-03
(104 days)
Product Code
EBZ
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
DENTMATE TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This LEDEX WL-070 is a visible curing unit programmed for polymerization of dental light cured materials by dental professionals.
Device Description
Not Found
Ask a Question
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