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510(k) Data Aggregation

    K Number
    K030436
    Device Name
    BIO UNIVERSAL
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2003-04-15

    (64 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BIO UNIVERSAL

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

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

    Device Description

    Bio Universal

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy device (BioUniversal). This type of document does not contain information about acceptance criteria for a medical device's performance, nor does it describe a study proving the device meets such criteria in the context of AI or advanced analytical performance.

    The document is a regulatory approval notice, confirming that the device is substantially equivalent to a legally marketed predicate device and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but does not delve into specific performance metrics or studies of the type you've outlined (e.g., diagnostic accuracy, expert consensus, training sets for AI).

    Therefore, I cannot extract the requested information from the provided text.

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