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510(k) Data Aggregation

    K Number
    K201410
    Device Name
    VENUS Bracket, ROSE Bracket
    Manufacturer
    GNI Co., LTD
    Date Cleared
    2021-03-12

    (288 days)

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

    GNI Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only.
    Device Description
    Orthodontic Ceramic bracket, VENUS and ROSE Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irreqular teeth and it requires additional rubber ring or ligating wire to fix Wire. VENUS Bracket no hook type and ROSE bracket have consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement. VENUS Bracket with hook type consist five parts: the slot for the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface; forth part is open guide part which serves as a path for movement of device used to open cap ligated to body; last part is different part from other type of models, it has self-ligating Clip to fix the teeth. These devices are designed for orthodontic use only. The devices intended use for single use only.
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    K Number
    K191041
    Device Name
    Orthodontic Fixation Screw [Smart Anchor Miniscrew]
    Manufacturer
    GNI Co., LTD
    Date Cleared
    2020-08-28

    (497 days)

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

    GNI Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is intended for use as a temporary anchor for orthodontic treatment for use in patients aged 12 and older.
    Device Description
    The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is an orthodontic screw used for straightening of irregular teeth. It is designed for indications such as malocclusion treatment, straightening of irregular teeth, improvement of intermaxillary space and occlusion, and maintenance after orthodontic treatment. It is surgically placed in the bone of the upper or lower jaw arches to provide support for orthodontic devices and it is used temporarily, removed after orthodontic treatment has been completed. Orthodontic screw is designed to facilitate placement of orthodontic appliances such as wires, springs, and elastic ligatures. Orthodontic Fixation Screw [Smart Anchor Miniscrew] is made of Titanium Alloy (T)-6AL-4V), which meets ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The head of the screw is through hole head type. The head of the Orthodontic Fixation Screw [Smart Anchor Miniscrew] is designed to apply various orthodontic tools. There is a hole in the screw head through which a wire can be passed to fix the mandible and maxilla in orthodontic treatment. Also, the design accommodates the use of the screw with the orthodontic appliances (bracket, wire, and elastic band etc.). The Orthodontic Fixation Screw [Smart Anchor Miniscrew] is available in in diameters of 1.2, 1.4, 1.6, 1.8, and 2.0mm and lengths of 8 and 10mm. The Orthodontic Fixation Screws with a diameter of 1.4mm and greater are also available in a 6mm length version.
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    K Number
    K182672
    Device Name
    ROSA Bracket
    Manufacturer
    GNI Co., LTD
    Date Cleared
    2019-11-15

    (415 days)

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

    GNI Co., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed. The devices are intended to be single use only
    Device Description
    Orthodontic Ceramic bracket, ROSA Bracket is an orthodontic bracket attached to teeth to recover aesthetics and function of malocclusion. Made with aluminum oxide, it is attached to teeth and straightens irregular teeth with orthodontic wire installed through the wire's elasticity. It is made with aluminum oxide and seeks smooth movement of orthodontic wire for straightening irregular teeth and it requires additional rubber ring or ligating wire to fix Wire. It consists of three parts: the first part is the slot for the orthodontic wire; the second part is a round groove that is to hold a wire with an elastic "O" ring; the third part is the base that adheres to the tooth surface. A colored marking on wing part of bracket indicates orientation for placement.
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