BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇪 Sweden

    TIGRAN PERIBRUSH

    K Number: K121114 · Decision Sep 17, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    158

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    Basic Information

    Device Name
    TIGRAN PERIBRUSH
    K Number
    K121114
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4840
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tigran Technologies AB
    Date Received
    April 12, 2012
    Decision Date
    September 17, 2012
    Product Code
    ELB
    Advisory Committee
    Dental
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ELB Scaler, Rotary

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