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

    3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS

    K Number: K952811 · Decision Aug 30, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    106
    Registration Numbers
    106
    Same Product Code
    291
    Applicant Total
    51
    Review Days
    72

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    Basic Information

    Device Name
    3I ORAL/MAXILLOFACIAL BONE FIXATION SYSTEM: STAINLESS STEEL BONE-MESH/PLATE & SCREWS
    K Number
    K952811
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.4760
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Innovations, Inc.
    Date Received
    June 19, 1995
    Decision Date
    August 30, 1995
    Product Code
    JEY
    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
    JEY Plate, Bone

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    Other Clearances by Implant Innovations, Inc.

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    K061629 CERTAIN PREVAIL DENTAL IMPLANT
    K062432 NANOTITE DENTAL IMPLANTS
    K061969 PREFORMANCE POSTS AND TEMPORARY CYLINDERS
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