LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K971727
    Device Name
    DCI WATER PURIFIER
    Manufacturer
    DENTAL COMPONENTS, INC.
    Date Cleared
    1997-09-12

    (126 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

    A device which provides water exposed Ultraviolet for a denta ( conjunction wit operate treatment devices, to veduce Water bacteria in the water number o

    Device Description

    Not Found

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter from the FDA for a dental water purifier. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, expert qualifications, or ground truth methods from this document.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1