BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇰🇷 South Korea

    ATOZ Mini-Screw

    K Number: K210559 · Decision Dec 19, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    51
    Applicant Total
    1
    Review Days
    297

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    Basic Information

    Device Name
    ATOZ Mini-Screw
    K Number
    K210559
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    872.3640
    Medical Specialty
    Dental
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mk Meditech, Inc.
    Date Received
    February 25, 2021
    Decision Date
    December 19, 2021
    Product Code
    OAT
    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
    OAT Implant, Endosseous, Orthodontic

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