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510(k) Data Aggregation

    K Number
    K183147
    Device Name
    BrackFix
    Manufacturer
    VOCO GmbH
    Date Cleared
    2019-03-01

    (108 days)

    Product Code
    DYH
    Regulation Number
    872.3750
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BrackFix

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

    Direct bonding of orthodontic metal and ceramic brackets

    Device Description

    Not Found

    AI/ML Overview

    This is an FDA 510(k) clearance letter for a dental adhesive (BrackFix) and does not contain the information requested about acceptance criteria and a study proving device performance as it relates to AI/ML devices.

    The letter confirms that the device BrackFix is intended for "Direct bonding of orthodontic metal and ceramic brackets" and has been determined to be substantially equivalent to legally marketed predicate devices. It does not refer to any AI/ML components or studies measuring AI/ML performance.

    Therefore, I cannot provide the requested information from this document.

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