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510(k) Data Aggregation

    K Number
    K012174
    Device Name
    ERIS LAYERING MATERIALS
    Manufacturer
    IVOCLAR NORTH AMERICA, INC.
    Date Cleared
    2001-08-27

    (46 days)

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

    ERIS LAYERING MATERIALS

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

    Eris Layering materials are porcelain powders used in our pressable ceramic system, Eris Layering materials are personal free single unit, and multiple unit bonded crown and bridge restorations.

    Device Description

    Eris Layering materials are porcelain powders used in our pressable ceramic system

    AI/ML Overview

    I am sorry, but the provided text is a standard FDA 510(k) clearance letter for a dental material (Eris Layering Materials). It establishes substantial equivalence to a predicate device and permits marketing.

    The document does not contain any information about:

    • Acceptance criteria for the device's performance.
    • Any study that proves the device meets specific acceptance criteria.
    • Device performance data.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth was established.

    Therefore, I cannot provide the requested information based on the input text.

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