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510(k) Data Aggregation

    K Number
    K021083
    Device Name
    VERACAM
    Manufacturer
    LUMALITE, INC.
    Date Cleared
    2002-08-30

    (149 days)

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

    LUMALITE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intra-oral camera system, Veracam, of Lumalite, Inc. is used to provide a view of the mouth so that it assists the dellife in describitits dollar procedures which the dentist has performed on him.
    Device Description
    Veracam; Intra-Oral Camera System and Accessories
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    K Number
    K002566
    Device Name
    LUMALITE CURE LIGHT, MODEL 2100
    Manufacturer
    LUMALITE, INC.
    Date Cleared
    2000-10-19

    (63 days)

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

    LUMALITE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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