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510(k) Data Aggregation

    K Number
    K063659
    Device Name
    EASY CURING PEN-STYLE LED CURING LIGHT
    Manufacturer
    DENT CORP. RESEARCH & DEVELOPMENT
    Date Cleared
    2007-04-30

    (143 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DENT CORP. RESEARCH **& DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Easy-Curing™ is a high intensity blue LED light source, used to polymerize standard, restorative materials, adhesives, and sealants which cure at a wavelength of 450 - 490 nm, off the shelf, dental curing materials in the dentist's clinic.
    Device Description
    The Easy-Curing™ is a high intensity blue LED light source.
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    K Number
    K020206
    Device Name
    INTRAORAL CAMERA ME-15
    Manufacturer
    DENT CORP. RESEARCH & DEVELOPMENT
    Date Cleared
    2002-04-11

    (79 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DENT CORP. RESEARCH **& DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ME-15 Intraoral Camera use only for photographing from a full mouth to a signal tooth. The ME-15 is not intended for any other use.
    Device Description
    Intraoral Camera ME-15
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    K Number
    K992233
    Device Name
    APEX LOCATOR BINGO-1020
    Manufacturer
    DENT CORP. RESEARCH & DEVELOPMENT
    Date Cleared
    1999-11-30

    (158 days)

    Product Code
    LQY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    **DENT CORP. RESEARCH **& DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BINGO-1020 is a modern device for precise apex localization during root channel treatment.
    Device Description
    BINGO-1020 is distinguished by increasing precision at 0.1mm on wet/dry, large graphic display where current position of endo file is reflected and other essential information is displayed.
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