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    K Number
    K121114
    Device Name
    TIGRAN PERIBRUSH
    Manufacturer
    TIGRAN TECHNOLOGIES AB
    Date Cleared
    2012-09-17

    (158 days)

    Product Code
    ELB
    Regulation Number
    872.4840
    Why did this record match?
    Applicant Name (Manufacturer) :

    TIGRAN TECHNOLOGIES AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tigran™ PeriBrush™ is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium Implant surfaces in bone defects caused by peri-implantitis.
    Device Description
    The Tigran™ PeriBrush™ is made of pure titanium (brush part) and nitinol (stem part). It is intended to use for mechanical debridement of surgically exposed dental titanium implant surfaces to remove plaque and calculus due to peri-implantitis. The product has a connector that fits into the head (chuck) of a dental handpiece accepting instruments complying with ISO 1797-1. The instrument is delivered sterile. The Tigran™ PeriBrush™ is for single use only.
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