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510(k) Data Aggregation

    K Number
    K222245
    Device Name
    ACR Screw System
    Manufacturer
    BioMaterials Korea, Inc
    Date Cleared
    2023-08-21

    (391 days)

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

    BioMaterials Korea, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth for use in patients 12 years of age and older. It is used temporarily and is removed after orthodontic treatment is complete. The screws are intended for single use only.
    Device Description
    The ACR Screw System is indicated for use as a fixed anchorage point for the attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment is complete. The average temporary implantation period for the anchorage screw is six months. Screws are intended for single use only. Screws are essentially C-type screw head design and size. Screw diameters and lengths are offered in the following range: thread diameter (1.75 mm) and overall length (11.10 – 15.10 mm). The screw tip has a self-drilling feature for insertion and removal. It is manufactured from a machined piece of Ti-6Al-4V ELI titanium alloy (ASTM F 136-13). These devices are supplied sterilized by gamma irradiation. This device is individually packaged in a polyethylene bag.
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    K Number
    K173623
    Device Name
    Anchor plate
    Manufacturer
    BioMaterials Korea, Inc
    Date Cleared
    2018-08-30

    (279 days)

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

    BioMaterials Korea, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The subject devices are intended to be place in the mouth for use as an anchor in orthodontic procedures.
    Device Description
    The anchor plates for attachment to the orthodontic device offer four types (T-Type, Y-Type and W-Type). This plate has three portions; head, arm and body, and there are two types of head portion. Anchor plate is developed to provide intraoral absolute anchorage for the intrusion or molars. Anchor Plate does not disturb any kind of tooth movement because they are placed outside the dentition. The anchor plate consists of pure titanium alloy, which is suitable for osseointegration and also tissue integration.
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