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    K Number
    K103586
    Device Name
    IOS FASTSCAN SPRAY
    Manufacturer
    IOS TECHNNOLOGIES, INC.
    Date Cleared
    2011-03-30

    (113 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    IOS TECHNNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IOS FastScan Spray is indicated as a coating medium for optical impressions with the IOS FastScan System. It aids in intraoral topographical recordings of prepared and unprepared teeth and their surroundings.
    Device Description
    The IOS FastScan Spray is a coating medium applied by a dentist, by spraying onto the area of interest on the teeth and gums. After the coating application, the IOS FastScan System is used to optically capture a 3D impression of the coated dentition. Once the dentist has completed the optical impression, the patient's mouth is rinsed and suctioned to remove the IOS FastScan Spray. The IOS FastScan Spray consists of a pigment suspension in ethanol with a fluorinated hydrocarbon propellant.
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