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510(k) Data Aggregation

    K Number
    K973088
    Device Name
    PLS-96P
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    1997-10-03

    (46 days)

    Product Code
    EJJ
    Regulation Number
    872.3070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

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

    Device Description

    PLS-96P Spherical Alloy

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental alloy device (PLS-96P Spherical Alloy). It states that the device is substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations it is subject to.

    The document does not contain information about:

    1. Acceptance criteria and reported device performance.
    2. Sample sizes or data provenance for a study.
    3. Number or qualifications of experts for ground truth.
    4. Adjudication methods.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes for AI assistance.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    Therefore, I cannot fulfill your request based on the provided text.

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