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510(k) Data Aggregation

    K Number
    K012831
    Device Name
    BIO PORTADUR, ORDER-NO.:2017
    Manufacturer
    WIELAND EDELMETALLE GMBH & CO.
    Date Cleared
    2001-11-01

    (70 days)

    Product Code
    EJT
    Regulation Number
    872.3060
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K891600
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BioPortadur is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing Inlays/ Onlays, Partial crowns, Crowns, Short span bridges, Long span bridges, Removable partials and can be used for Telescopic and milling work.

    Device Description

    BioPortadur is an extra-hard gold casting alloy (96% noble metals), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. BioPortadur is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices.

    AI/ML Overview

    The provided text focuses on regulatory approval for a dental alloy, BioPortadur, and does not contain information about acceptance criteria or a study demonstrating device performance. The text is a 510(k) summary and approval letter, which describes the device, its intended use, and its substantial equivalence to a predicate device, rather than detailed performance data from a specific study.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results.
    6. Standalone performance study details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. Method for establishing ground truth for the training set.

    The document states that BioPortadur "fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices." However, it does not provide the specific acceptance criteria within ISO 1562 or details of a study that directly verifies and reports performance against those criteria. It only asserts compliance.

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