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510(k) Data Aggregation

    K Number
    K020171
    Device Name
    COOLBLU2 DENTAL RESIN CURING DEVICE
    Manufacturer
    DENTAL SYSTEMS.COM, INC.
    Date Cleared
    2002-01-29

    (12 days)

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

    DENTAL SYSTEMS.COM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CoolBlu2 curing light is intended as a source of illumination for the curing of dental restorative materials.
    Device Description
    CoolBlu2 Dental Resin Curing Device
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    K Number
    K002925
    Device Name
    COOLBLU CURING LIGHT
    Manufacturer
    DENTAL SYSTEMS.COM, INC.
    Date Cleared
    2000-12-20

    (92 days)

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

    DENTAL SYSTEMS.COM, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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