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

    OsteoReady Dental Implant System

    K Number: K173575 · Decision Aug 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    333
    Registration Numbers
    333
    Same Product Code
    1516
    Applicant Total
    2
    Review Days
    270

    Basic Information

    Device Name
    OsteoReady Dental Implant System
    K Number
    K173575
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OsteoReady LLC
    Date Received
    November 20, 2017
    Decision Date
    August 17, 2018
    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 OsteoReady LLC

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