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510(k) Data Aggregation

    K Number
    K152297
    Device Name
    OBS Anchorage Screw
    Manufacturer
    BOMEI CO., LTD
    Date Cleared
    2016-02-09

    (180 days)

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

    BOMEI CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Temporary anchorage screws are intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and is removed after orthodontic treatment has been completed.
    Device Description
    OBS Anchorage Screw consists of stainless steel (ISO 5832-1:2007/ASTM F138-13) and titanium alloy (ISO 5832-3:1996/ASTM F136-13) self-tapping screw with various sizes for applications in the orthodontic field. It is intended to serve as a fixed anchorage point for the attachment of orthodontic and preprosthetics appliances, in order to facilitate the orthodontic movement of teeth. OBS Anchorage Screw is available in the following diameter and length. - Diameter ( Ø1.5 mm ) x Length ( 8 / 10 / 12 mm ) . - Diameter ( Ø2.0 mm ) x Length ( 8 / 10 / 12 / 14 mm ) . There are three types of OBS Anchorage Screw. - . Square collar mushroom head none hole - . Square collar mushroom head round hole - Square collar mushroom head slot hole . OBS Anchorage Screw and associated accessories are supplied non-sterile and should be sterilized before use. The sterilization recommendations documented in the instructions for use (IFU) are according to "AAMI / ANSI ST79 Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities" have been validated. Use a pre-vacuum sterilization method minimum 4 minutes at a temperature of 132°C (270°F). Drying time is 30 minutes. The devices are used temporarily with the intention to be removed after orthodontic treatment. Screws are intended for single use only.
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