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510(k) Data Aggregation

    K Number
    K032152
    Device Name
    BENCO ADMIX
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2003-08-06

    (70 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    BENCO ADMIX

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

    Silver based alloy dental restorative used in all classes of restorations.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental alloy. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Specifically:

    1. Acceptance criteria and reported device performance: Not present. This document is a regulatory clearance, not a performance report.
    2. Sample size, data provenance: Not present.
    3. Number of experts and qualifications: Not present.
    4. Adjudication method: Not present.
    5. MRMC comparative effectiveness study: Not present.
    6. Standalone performance study: Not present.
    7. Type of ground truth: Not present.
    8. Sample size for training set: Not present.
    9. How ground truth for training set was established: Not present.

    The document discusses the regulatory determination of substantial equivalence for the "Benco Admix" dental restorative, indicating it's an amalgam alloy used in all classes of restorations. It refers to general controls and existing regulations but does not detail any performance studies or their associated acceptance criteria.

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