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510(k) Data Aggregation

    K Number
    K222738
    Device Name
    Point implant system
    Manufacturer
    Date Cleared
    2023-04-13

    (216 days)

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

    PointNix Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Point implant system is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.
    Device Description
    Point implant system is a dental implant system consisting of fixtures, mount & mount screws, abutments (cemented, solid, angled, temporary, healing), abutment screws, and cover screws. The applied part is oral and the contact duration is C (>30 days). The patient population is dental prosthetic patients. The materials used include Unalloyed Titanium (ASTM F67), Alloyed Titanium (ASTM F136), and Polyoxymethylene (CAS No.: 30846-29-8).
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    K Number
    K121800
    Device Name
    POINT 500 HD POINT500C HD
    Manufacturer
    Date Cleared
    2013-01-24

    (219 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    POINTNIX CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Point 500 HD/500C HD which is the dental panoramic/panoramic and cephalometric device is intended to produce diagnostic quality radiographic images by acquiring digital 2D X-ray images. The cephalometric system produces cephalomertric radiographic images that maybe used in orthodontic diagnosis procedures.
    Device Description
    The Point 500 HD/500C HD is a dental panoramic and cephalometric device which is digital X-ray imaging device. It is intended for dental radiographic examinations of teeth, jaw and TMJ areas by exposing X-ray and then converts this information to the digital signals to acquire images. High-defined images are provided by controlling acquired image with computer and this is used to obtain panoramic and cephalometric images for dental purpose. This equipment is equipped with an X-ray generator and Sensor for panoramic and cephalometric at Rotation unit which are supported by Main frame and Column. When rotation unit is rotating around the patient's teeth and jaw for acquiring panoramic image, X-ray exposes and sensor detects the data from X-ray generator. Detected data from each frame is transferred to PC, and combined together to display panoramic image on PC screen by installed software on PC.
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