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510(k) Data Aggregation

    K Number
    K964942
    Device Name
    INFECTION CONTROL CARTRIDGE
    Manufacturer
    DENTALPURE CORP.
    Date Cleared
    1997-06-19

    (191 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FOR USE TO REDUCE BACTERIA AND VIRUSES PRESENT IN DENTAL UNIT WATER LINE WATER. THE DEVICE CAN BE USED ON THE GENERAL PATIENT POPULATION, WITH THE EXCEPTION OF PATIENTS WHO ARE PREGNANT OF WHO ARE SENSITIVE TO IODINE.

    Device Description

    DENTAL UNIT WATER TREATMENT CARTRIDGE

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) clearance letter from the FDA to Dentalpure Corporation for a "Dental Unit Water Treatment Cartridge."

    It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and outlines the general controls provisions of the Federal Food, Drug, and Cosmetic Act that apply to the device. The document also includes the indications for use of the device.

    Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as this information is not present in the provided text.

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