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510(k) Data Aggregation

    K Number
    K192015
    Device Name
    Faico Dental Implant System
    Manufacturer
    FAICO Medical LLC
    Date Cleared
    2020-04-03

    (249 days)

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

    Immediate loading when good primary stability is achieved and with appropriate occlusal loading for use in surgical (single-stage or two-stage procedures) and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic device such as artificial teeth and to restore the patient's chewing function. The System is intended to be used in either single tooth or multiple teeth applications.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Faico Dental Implant System. It does not contain information about acceptance criteria, device performance, study details, human reader studies, or ground truth establishment relevant to AI/ML device evaluations.

    Therefore, I cannot extract the requested information from this document. The document primarily focuses on the regulatory clearance of a physical medical device (dental implants) and does not describe any AI/ML components or performance studies for such components.

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