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510(k) Data Aggregation

    K Number
    K970042
    Device Name
    OOLI-U(TONGUE SCRAPER)
    Manufacturer
    TELEFAX INTL.
    Date Cleared
    1997-03-14

    (67 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K961574
    Why did this record match?
    Device Name :

    OOLI-U(TONGUE SCRAPER)

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

    The device is intended to remove plaque and food debris from the surface of the tongue.

    Device Description

    The device is a formed piece of stainless steel.

    AI/ML Overview

    The provided text describes a 510(k) summary for a tongue scraper, focusing on its safety, effectiveness, and comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that a device meets those criteria.

    The document states:

    • "Summary of Performance Data: Not Applicable."
    • "Conclusions Drawn From Nonclinical and Clinical Tests: Not Applicable."

    This clearly indicates that no performance studies, clinical or non-clinical, were conducted or are being reported in this submission for this specific device. The submission relies solely on the substantial equivalence to a predicate device (U.S. Dentek' Sakool, K961574) and the fact that the only known difference is the material (stainless steel vs. plastic), with the claim that "From using these devices, the results are the same."

    Therefore, I cannot provide the requested information, as it is not present in the input text.

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