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510(k) Data Aggregation

    K Number
    K030435
    Device Name
    BIOUNIVERSAL PKF
    Date Cleared
    2003-04-15

    (64 days)

    Product Code
    Regulation Number
    872.3060
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Bio Universal PKF alloy intended to be used for crowns, posts, short and long span bridges and PFM crowns.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental alloy, BioUniversal PKF. This type of document is a regulatory approval and does not contain information about acceptance criteria or a study proving device performance against such criteria.

    The purpose of a 510(k) clearance is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its absolute safety and effectiveness through a new study with acceptance criteria.

    Therefore, I cannot provide the requested information from the given text.

    To answer your request, I would need a different type of document, such as a clinical study report, a performance validation report, or a detailed product specification document that outlines specific performance criteria and the results of tests conducted to meet them.

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