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510(k) Data Aggregation

    K Number
    K071615
    Device Name
    FIXAFLOSS
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2007-09-21

    (100 days)

    Product Code
    EEF
    Regulation Number
    872.6300
    Why did this record match?
    Product Code :

    EEF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the FixaFloss is to be placed between teeth for the fixation of rubber dams. The FixaFloss is a waxed dental floss with a silicone conical clamping element intended to be placed between teeth for rubber dam fixation.
    Device Description
    The FixaFloss is a waxed dental floss assembled with 1 size and 1 color silicone conical resilient clamping element packaged as a one string product containing 20 resilient connes in a hygienic dispenser with an integrated cutting blade.
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