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

    HALL ORAL IMPLANT SYSTEM

    K Number: K864734 · Decision Feb 10, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    8
    Review Days
    68

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    Basic Information

    Device Name
    HALL ORAL IMPLANT SYSTEM
    K Number
    K864734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Applicant
    Hall Surgical, Division of Zimmer, Inc.
    Date Received
    December 4, 1986
    Decision Date
    February 10, 1987
    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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    Other Clearances by Hall Surgical, Division of Zimmer, Inc.

    K Number Device Name
    K942660 HALL MICROCHOICE ELECTRIC POWERED SYSTEM
    K864929 HALL (R) MICRO E POWERED SURGICAL INSTRUMENT SYST
    K864163 HALL DUNBAR DRILL GUIDE SYSTEM
    K862778 HALL CANNLULA SYSTEM
    K862474 HALL STERNUM SAW
    K862529 HALL STERILE BUR
    K852143 HALL IRRIGATION SYSTEM