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

    OsteoReady ZircoSeal Abutments

    K Number: K151169 · Decision Oct 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    390
    Registration Numbers
    390
    Same Product Code
    672
    Applicant Total
    2
    Review Days
    160

    Basic Information

    Device Name
    OsteoReady ZircoSeal Abutments
    K Number
    K151169
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3630
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OsteoReady LLC
    Date Received
    May 1, 2015
    Decision Date
    October 8, 2015
    Product Code
    NHA
    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
    NHA Abutment, Implant, Dental, Endosseous

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    Other Clearances by OsteoReady LLC

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