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

    Implant Direct Dental Implant Systems Portfolio - MR Conditional

    K Number: K222211 · Decision Feb 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    324
    Registration Numbers
    324
    Same Product Code
    1545
    Applicant Total
    17
    Review Days
    192

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    Basic Information

    Device Name
    Implant Direct Dental Implant Systems Portfolio - MR Conditional
    K Number
    K222211
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Implant Direct Sybron Manufacturing, LLC
    Date Received
    July 25, 2022
    Decision Date
    February 2, 2023
    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 Implant Direct Sybron Manufacturing, LLC

    K Number Device Name
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    K200858 Mini Sterilizable Tray
    K200265 Surgical Drills
    K192221 Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts
    K192218 Custom Legacy and Custom InterActive Titanium Abutments
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    K181359 InterActive SMARTBase Abutments
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