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

    THE AUTOTAC SYSTEM

    K Number: K993493 · Decision Jan 7, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    71
    Registration Numbers
    71
    Same Product Code
    79
    Applicant Total
    40
    Review Days
    84

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    Basic Information

    Device Name
    THE AUTOTAC SYSTEM
    K Number
    K993493
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4880
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    BioHorizons Implant Systems, Inc.
    Date Received
    October 15, 1999
    Decision Date
    January 7, 2000
    Product Code
    DZL
    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
    DZL Screw, Fixation, Intraosseous

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