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510(k) Data Aggregation

    K Number
    K980075
    Device Name
    CYBERSONIC
    Manufacturer
    AMERICAN DENTRONICS, INC.
    Date Cleared
    1998-03-04

    (55 days)

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

    AMERICAN DENTRONICS, INC.

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

    Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Cybersonic" with K980075. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter simply states that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.

    Therefore, I cannot provide the requested information from this document.

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