LogoFDA 510(k) Search
Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K170596
    Device Name
    TN-Brush
    Manufacturer
    GENOSS Co. Ltd.
    Date Cleared
    2017-09-11

    (195 days)

    Product Code
    ELB
    Regulation Number
    872.4840
    Why did this record match?
    Product Code :

    ELB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TN-Brush 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
    Not Found
    Ask a Question
    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?
    Product Code :

    ELB

    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.
    Ask a Question
    K Number
    K111724
    Device Name
    STRAUMANN TIBRUSH
    Manufacturer
    STRAUMANN USA
    Date Cleared
    2011-09-12

    (84 days)

    Product Code
    ELB
    Regulation Number
    872.4840
    Why did this record match?
    Product Code :

    ELB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Straumann® TiBrush 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 Straumann® TiBrush is made of Grade 5 Titanium and stainless steel for single patient use and is attached to a dental handpiece. It is used during open flap surgery to remove biofilms (plaque and calculus) from the surfaces of dental implants where the surface of the implant is exposed due to peri-implantitis. The TiBrush mechanically removes the biofilms from the surface of the implants without damaging the integrity of the roughened implant surface.
    Ask a Question
    K Number
    K003640
    Device Name
    MINIENDO III
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2001-02-22

    (87 days)

    Product Code
    ELB
    Regulation Number
    872.4840
    Why did this record match?
    Product Code :

    ELB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

    Page 1 of 1