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510(k) Data Aggregation

    K Number
    K140202
    Date Cleared
    2014-12-12

    (319 days)

    Product Code
    Regulation Number
    872.3640
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Trausim Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient The Trausim Dental Implants System's prosthetic components include abutment, healing cap and screw. The abutment is as dental implant systems essentially a connection part of dental implant and denture. The healing cap is used for covering the dental implant during healing period; the aim at avoiding soft tissue (gingival) get into the hole of dental implant, and shaping the gingival aesthetic form.

    Device Description

    The Trausim Dental Implants System's prosthetic components include abutment, healing cap and screw. The abutment is as dental implant systems essentially a connection part of dental implant and denture. The healing cap is used for covering the dental implant during healing period; the aim at avoiding soft tissue (gingival) get into the hole of dental implant, and shaping the gingival aesthetic form.

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental implant system. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from this document.

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