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510(k) Data Aggregation

    K Number
    K992270
    Device Name
    MIRACLEBREATH TONGUE CLEANER
    Manufacturer
    STELLAR LABS, INC.
    Date Cleared
    1999-09-23

    (79 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K962941,K983683
    Why did this record match?
    Applicant Name (Manufacturer) :

    STELLAR LABS, INC.

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

    To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.

    Device Description

    The device is a natural polypropylene band. It is formed into a u-shape by holding each end with the finger tips. The device is then placed on the back of the tongue and pulled forward gently with either the flat or rippled edge down. There are no sharp edges on the device.

    AI/ML Overview

    The provided document is a 510(k) summary for the "MiracleBreath Tongue Cleaner," a manual tongue scraper.

    This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) summary focuses on the device description, contact information, and its substantial equivalence to predicate devices (other tongue cleaners) for its intended use (removing plaque and food debris from the tongue to help fight bad breath and promote oral hygiene).

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met because this information is not present in the provided text.

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