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

    ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX

    K Number: K080074 · Decision Feb 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    21
    Review Days
    34

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    Basic Information

    Device Name
    ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
    K Number
    K080074
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Ace Surgical Supply Co., Inc.
    Date Received
    January 11, 2008
    Decision Date
    February 14, 2008
    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 Ace Surgical Supply Co., Inc.

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    K021244 ACE HA SCREW DENTAL IMPLANT SYSTEM
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