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510(k) Data Aggregation

    K Number
    K980842
    Device Name
    COPPER TONGUE SCRAPER
    Manufacturer
    ONTEL PRODUCTS CORP.
    Date Cleared
    1998-05-20

    (77 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K961574,K970042
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONTEL PRODUCTS CORP.

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

    Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.

    Device Description

    This device is a U-formed design made of Copper.

    AI/ML Overview

    The provided text does not contain any information about acceptance criteria or a study demonstrating that the device meets such criteria.

    The document is a 510(k) summary for the Copper Tongue Scraper, which focuses on establishing substantial equivalence to predicate devices rather than presenting performance metrics against specific acceptance criteria.

    Therefore, I cannot populate the requested table or answer the questions based on the provided input.

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