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510(k) Data Aggregation

    K Number
    K050408
    Manufacturer
    Date Cleared
    2005-04-07

    (49 days)

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

    BICON ORTHODONTIC IMPLANT SYSTEM

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

    The Bicon Orthodontic Implant System is intended for those cases where a clinician desires to provide a fixed point of anchorage to which orthodontic appliances may be attached to orthodontically move teeth. The system consists of a small implant that is screwed into the jawbone that will be removed after completion of treatment.

    Device Description

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    AI/ML Overview

    I am sorry, but this document contains a medical device approval letter from the FDA. It does not include information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device's performance. Therefore, I cannot fulfill your request based on the provided text.

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