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510(k) Data Aggregation

    K Number
    K033773
    Device Name
    CONCEPT HP ADD-ON; CONCEPT HP ENAMEL
    Manufacturer
    IVOCLAR VIVADENT AG
    Date Cleared
    2004-01-15

    (43 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Concept HP Add-On is light cured resin material for the preparation of indirect inlay and onlay dental restorations
    Concept HP Enamel is heat and pressure cured resin material to be used for the Concept in indirect inlay and onlay dental restorations.
    The materials are contraindicated for: Veneers Metal supported crown & bridges Metal Supporty cemented metal-free restorations Patients with occlusal dysfunction, parafunctions Patients with insufficient oral hygiene

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) Pre-market Notification letter from the FDA for a dental device (Concept HP Add-On and Concept HP Enamel). It confirms substantial equivalence to a predicate device for marketing purposes.

    However, this document does not contain any information regarding:

    • Acceptance criteria for device performance.
    • The details of a study that proves the device meets specific acceptance criteria.
    • Sample sizes for test sets or training sets.
    • Data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types.

    Therefore, I cannot provide the requested information based on the given document. This FDA letter simply states that the device is substantially equivalent to existing devices and can be marketed, without detailing performance studies or their results.

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