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510(k) Data Aggregation

    K Number
    K111167
    Device Name
    XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2011-08-18

    (114 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    VELOPEX INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ExtraXtender Film Processor is an automatic film processor used by dental offices to develop X-ray films. The Extra Xtender processes all film sizes of intra-oral and extra oral film. High quality archivable radiographs are delivered dry in 5 minutes. Films may be viewed wet after 2 1/2 minutes. The Sprint Film Processor is an automatic film processor used by dental offices to develop xray films. The Sprint Film Processor processes all sizes of intra-oral film. Films may be viewed wet after 2 1/2 minutes.
    Device Description
    Automatic Film processor
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    K Number
    K093503
    Device Name
    INTRAX FILM PROCESSOR
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2010-01-06

    (55 days)

    Product Code
    IXW
    Regulation Number
    892.1900
    Why did this record match?
    Applicant Name (Manufacturer) :

    VELOPEX INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IntraX Film Processor is an Automatic film processor used by dental offices to develop x-ray films. all sizes of intra - oral film .
    Device Description
    IntraX Film Processor Trade Name: IntraX Film Processor Common Name: Automatic Film processor Classification name: Processor, Radiographic-Film, Automatic Device Class 2 Regulation Number: 892.1900
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    K Number
    K024105
    Device Name
    VELOPEX AQUACUT FLUID ABRASION UNIT
    Manufacturer
    VELOPEX INTERNATIONAL, INC.
    Date Cleared
    2003-10-09

    (300 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    VELOPEX INTERNATIONAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FOR PIT AND FISSURE SEALANTS. PREPARATION REMOVAL AND RESICRATION OF COMPOSITS . CAVITY PREPARATION. CLEANING, POLISHING AND STAIN REMOVAL,
    Device Description
    Not Found
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