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510(k) Data Aggregation

    K Number
    K110275
    Device Name
    ORTHO EASY PIN
    Manufacturer
    FORESTADENT BERNHARD FORSTER GMBH
    Date Cleared
    2011-06-03

    (123 days)

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

    FORESTADENT BERNHARD FORSTER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended to provide a fixed anchorage point for the 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. The screws are intended for single use only.
    Device Description
    The Ortho Easy Pin is designed for use in orthodontic treatments as element of anchorage. The screws are made of titanium alloy. The slots in the screw head are cross-shaped. Rectangular wires are inserted to accommodate orthodontic elements, such as arches, elastic bands and brackets. Preferably, the wire should be fixed to the screw head using an elastic band or steel ligature. A retention groove below the slots serves as the anchor for fixing elements in the slot. The thread of the Pin is self-trapping and self-drilling. The Pin is inserted and screwed into the bone either manually or mechanically. To insert the screw, the hexagon head of the screw is picked up using an instrument. The sleeve between the thread and the functional head serves to protect the soft tissue. These screws are supplied non-sterile. Therefore, the device must be sterilized prior to use. Steam sterilization is recommended. The device is available in different lengths (6, 8, 10, 12 mm), diameter 1,7 mm, and supplied in sealed polyethylene bags.
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    K Number
    K090933
    Device Name
    BERNHARD-FORSTER GMBH ORTHODONTIC CERAMIC BRACKETS
    Manufacturer
    FORESTADENT BERNHARD FORSTER GMBH
    Date Cleared
    2009-06-05

    (64 days)

    Product Code
    NJM
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    FORESTADENT BERNHARD FORSTER GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single used only.
    Device Description
    The Orthodontic Ceramic Brackets are bonded to teeth to apply forces to the tooth, transmitted through a flexible orthodontic wire , to alter the tooth position. The ceramic bracket has both, aesthetic and self ligating qualities. This aimed at facilitating easier orthodontic wire placement and removal through self- ligatation. The function and performance of the orthodontic ceramic brackets are equal to the predicate device. The Material was selected according the requirements of ISO 6474;1994. Ceramic materials based on High purity aluminia.
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