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510(k) Data Aggregation

    K Number
    K133824
    Device Name
    CERASMART
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2014-03-14

    (87 days)

    Product Code
    EBF,EBG
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K110131,K123631,K082171
    Why did this record match?
    Device Name :

    CERASMART

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

    The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.

    Device Description

    CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth.

    AI/ML Overview

    The provided document describes the 510(k) summary for CERASMART, a pre-cured composite block for milling CAD/CAM indirect dental restorations. The submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study with acceptance criteria and a detailed study report. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not available in this document.

    Here's a breakdown of the information that can be extracted:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds that were met by a study. Instead, it presents performance testing results for the applicant device (CERASMART) and compares them with predicate devices, implying that equivalent or improved performance is desired. The comparison in the table below is qualitative, based on the provided data.

    Performance AttributeAcceptance Criteria (Implied/Compared to Predicate)Reported Device Performance (CERASMART)
    Flexural strength/MPa(Implied: Comparable to or better than predicate devices)Performance data is listed in section 8, but specific values are not provided in the summary.
    Water Sorption/ug/mm3(Implied: Comparable to or better than predicate devices)Lower than 3M Lava Ultimate (K110131) as noted in the "Differences" section. Specific values are not provided.
    Solubility/ug/mm3(Implied: Comparable to or better than predicate devices)Performance data is listed in section 8, but specific values are not provided in the summary.
    Radiopacity(Implied: Comparable to or better than predicate devices)Performance data is listed in section 8, but specific values are not provided in the summary.

    2. Sample Size Used for the Test Set and Data Provenance

    This information is not provided in the 510(k) summary. The document focuses on material properties and comparison to predicate devices, not on a clinical trial or a test set of patient data.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

    This information is not provided as there is no mention of a test set requiring expert ground truth establishment for a diagnostic or AI-driven device. This submission is for a dental restorative material, not a diagnostic tool.

    4. Adjudication Method for the Test Set

    This information is not provided for the same reasons as above.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms that assist human readers. CERASMART is a dental restorative material.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    No, a standalone performance study was not done. This is not an AI or algorithm-driven device.

    7. The Type of Ground Truth Used

    This information is not applicable as there is no diagnostic or AI component requiring a ground truth. The "ground truth" in this context would generally refer to the established physical and chemical properties measured during bench testing of the material itself.

    8. The Sample Size for the Training Set

    This information is not applicable as there is no AI algorithm being trained.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable as there is no AI algorithm being trained.

    Summary of Device and Study Focus:

    The K133824 submission for CERASMART is a substantial equivalence (SE) application for a Class II dental restorative material. The "study" referenced in the document is primarily bench testing to demonstrate the material's physical and chemical properties (e.g., flexural strength, water sorption, solubility, radiopacity) and comparing them to legally marketed predicate devices. The "acceptance criteria" are implicitly met by demonstrating that CERASMART is "substantially equivalent" to the predicate devices in terms of function, composition, and intended use, with comparable or improved performance in relevant material properties.

    The document highlights:

    • Predicate Devices: 3M ESPE Dental Products LAVA Ultimate (K110131), GC America Inc. MFP-051 (K123631), and GC America Inc. GRADIA CORE (K082171).
    • Technological Characteristics: All components of CERASMART have been previously used in MFP-051 and GRADIA CORE.
    • Differences Noted: CERASMART has lower water sorption than 3M Lava Ultimate. MFP-051 and Gradia Core are not pre-cured, unlike CERASMART.
    • Conclusion: The submission concludes that CERASMART is substantially equivalent to the predicate devices based on its function, composition, and intended use, supported by performance testing data (though specific numerical results are not detailed in this summary).
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