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510(k) Data Aggregation

    K Number
    K111958
    Device Name
    TETRIC EVOCERAM BULK FILL
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2011-10-14

    (95 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TETRIC EVOCERAM BULK FILL

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

    Restoration of Deciduous teeth Restorations in the posterior region (Classes I and ii) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Extended fissure sealing in molars and premolars

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a dental filling material (Tetric EvoCeram Bulk Fill). It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

    The document discusses:

    • The FDA's determination of substantial equivalence for the dental material.
    • Regulatory classifications and requirements for medical devices.
    • Indications for use for the Tetric EvoCeram Bulk Fill material (restoration of deciduous teeth, posterior restorations (Classes I and II), Class V restorations, and extended fissure sealing).

    In summary, the provided text does not contain the information necessary to answer your request about acceptance criteria and device performance evaluation for an AI/ML product.

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    K Number
    K042819
    Device Name
    TETRIC EVOCERAM
    Manufacturer
    IVOCLAR VIVADENT, INC.
    Date Cleared
    2004-11-09

    (28 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TETRIC EVOCERAM

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

    Intended Use:
    Anterior restorations (Class III, IV) Class V restorations (cervical caries, root erosion, wedge-shaped defects) Restorations in the posterior region (Class I and II) Veneering of discolored anterior teeth Splinting of mobile teeth Repair of composite and ceramic veneers

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) K042819 letter for "TETRIC EVOCERAM" only constitutes a clearance letter for a dental resin material. It does not contain any information about a study with acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement as typically related to the evaluation of AI/ML-driven medical devices.

    The document is a standard FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices. It lists the indications for use of the dental resin.

    Therefore, I cannot extract the requested information regarding acceptance criteria, study details, and performance metrics because it is not present in the provided text.

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