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510(k) Data Aggregation

    K Number
    K982616
    Device Name
    IPS EMPRESS 2
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    1998-09-08

    (43 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IPS EMPRESS 2

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

    Metal free single unit and anterior multiple unit Bonded Crown and Bridge Restoration

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental restoration device, IPS Empress 2. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt. This type of information would typically be found in a more detailed submission summary, clinical study reports, or performance testing documentation, which are not part of this clearance letter.

    Therefore, I cannot fulfill your request with the provided input. The document merely confirms the FDA's decision to allow the device to be marketed.

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