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510(k) Data Aggregation

    K Number
    K071851
    Manufacturer
    Date Cleared
    2007-10-18

    (105 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    HDC STERILE SPIDER SCREW

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HDC Sterile Spider Screw is a threaded titanium dental implant screw, intended to serve as a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of the teeth. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only.

    Device Description

    The HDC Sterile Spider Screw is a titanium fixation device to be inserted into the upper or lower jaws. designed to be immediately used (after the bone insertion) as fixation for orthodontic appliances. It is used temporarily and must be removed after the orthodontic treatment has been completed. It is provided sterile and is intended for single use only. The Sterile Spider Screw is provided in two configuration "Self Tapping" and "Self Drilling and Self Tapping." Self Tapping Spider Screw is manufactured from ASTM F67 and ASTM F136. Self Drilling and Self Tapping Spider Screw is manufactured from ASTM F136. HDC Sterile Spider Screw is provided in three tip size diameters: 1.3 mm, 1.5 mm and 2.0 mm.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) summary for a medical device (HDC Sterile Spider Screw) to establish substantial equivalence to predicate devices, rather than a performance study report.

    Therefore, I cannot provide the requested table or details about a study.

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