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510(k) Data Aggregation

    K Number
    K031658
    Device Name
    BENCO SPHERICAL
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2003-07-29

    (62 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 SPHERICAL

    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) premarket notification letter from the FDA regarding a dental restorative material, "Benco Spherical." This document confirms the device's substantial equivalence to a predicate device and permits its marketing. It does not contain information about acceptance criteria, device performance studies, or details relevant to the specific questions posed (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details). These types of details are typically found in the 510(k) submission itself, which is not provided here, rather than in the FDA's decision letter.

    Therefore, I cannot provide the requested information based solely on the provided text. The document is a regulatory approval letter, not a technical report on device performance.

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