BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS

    K Number: K894844 · Decision Feb 2, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    1
    Review Days
    186

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    Basic Information

    Device Name
    BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS
    K Number
    K894844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Straumann Institute, Ltd.
    Date Received
    July 31, 1989
    Decision Date
    February 2, 1990
    Product Code
    DZE
    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
    DZE Implant, Endosseous, Root-Form

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