LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971025
    Device Name
    AYURVEDIC TONGUE CLEANER
    Manufacturer
    CALELLO MARTINEZ P.C.
    Date Cleared
    1997-05-22

    (63 days)

    Product Code
    LCN
    Regulation Number
    872.6855
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Ayurvedic Tongue Cleaner is a device used to remove food particles and debris from the tongue. It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding an "Ayurvedic Tongue Cleaner." This document primarily addresses the substantial equivalence determination of the device to legally marketed predicate devices, allowing its market entry. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment—all of which are typical components of a technical study report for a medical device.

    Therefore, I cannot fulfill your request for this information based on the provided text. The document is regulatory approval, not a performance study.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1