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510(k) Data Aggregation

    K Number
    K210559
    Device Name
    ATOZ Mini-Screw
    Manufacturer
    MK Meditech Inc.
    Date Cleared
    2021-12-19

    (297 days)

    Product Code
    OAT
    Regulation Number
    872.3640
    Why did this record match?
    Applicant Name (Manufacturer) :

    MK Meditech Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ATOZ Mini-Screw is intended for use as a temporary anchor for orthodontic treatment.
    Device Description
    The ATOZ Mini-Screw is a temporary screw used as a fixing point for orthodontic treatment. The screw head has a round shape and has a cross groove in the middle so that it can be inserted and removed with a dental screwdriver. The ATOZ Mini-Screw has several models of the same design and diameter, only different lengths. The material of The ATOZ Mini-Screw is Titanium Alloy (ASTM F136). It is single-use only and may not be reused. The average implantation period of the set screw is 6 months and must be used after autoclaving by the user before use.
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