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510(k) Data Aggregation

    K Number
    K973086
    Device Name
    PLA-96P
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    1997-10-07

    (50 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

    PLA-96P Admix Alloy

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental restorative material named PLA-96P Admix Alloy. It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the letter does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or specific study results. This type of information is typically found in the 510(k) submission itself, which is not provided here.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided document. The document only confirms the FDA's decision regarding substantial equivalence.

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