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510(k) Data Aggregation

    K Number
    K040117
    Device Name
    UNIPORT SELF-CONTAINED PORTABLE DENTAL UNIT
    Date Cleared
    2004-04-21

    (92 days)

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

    ARROW INDUSTRIES LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This device is intended for delivery of general restorative dental care for those who cannot visit the dental office.
    Device Description
    The UNIPORT has been designed to provide ease in set-up and transportation as well as good dental care. Reliable air supply being an utmost necessity, it has 9.8 L of air storage supplied by a 3/4 hp compressor to maintain pressure during daily practice. For ease in set-up, take-down, and transport, the UNIPORT is truly self-contained - all components are mounted in a lightweight unitized cabinet with wheels. The cabinet, a shell containing the operational components, is made of food grade polyethylene for durability; its smooth exterior is easy to wipe down and disinfect between operations. While the outside of the UNIPORT appears different to others, the actual operating components are similiar to those used in dental clinics around the nation.
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