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510(k) Data Aggregation

    K Number
    K081537
    Device Name
    CFS FLEXIBLE
    Manufacturer
    COMFORT AND FLEXIBLE SYSTEMS
    Date Cleared
    2009-01-22

    (234 days)

    Product Code
    EBI
    Regulation Number
    872.3760
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    Applicant Name (Manufacturer) :

    COMFORT AND FLEXIBLE SYSTEMS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CFS FLEXIBLE™ is a break resistant material used in the fabrication and repair of base plates for removable dental prosthetic appliances where superior flexibility and patient comfort for the lifetime of the prosthetic are significant concerns. This includes, but not limited to, full and partial dentures, orthodontic devices, occlusal splints, and night guards.
    Device Description
    CFS FLEXIBLE™ is an injection moldable, flexible, thermoplastic nylon with trace amount of colorant added. CFS FLEXIBLE™ is used for fabricating removable dental prosthetic appliances such as in and partial dentures, orthodontics devices, occlusal splints and night guards both permanent and temporary. Because it can be used to create completely non-metallic prosthetics, it is perfect for making removable dental prosthetic appliances for metal-allergic patients.
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