LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K982117
    Device Name
    FLUID CONTROL
    Manufacturer
    T.A. COLEMAN ENT.
    Date Cleared
    1998-09-04

    (80 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

    The FLUID CONTROL device is a dental operative unit accessory that allows for the controlled delivery of a particular rate of air and/or fluid from a pressurized source during various dental procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "Fluid Control." This document primarily focuses on the FDA's decision of substantial equivalence for the device to legally marketed predicate devices, allowing it to be marketed.

    Crucially, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any comparative effectiveness studies. These details are typically found in the device's 510(k) submission summary or a separate performance study report, not in the FDA's decision letter itself.

    Therefore, I cannot provide the requested information based solely on the provided text. The document confirms the device's regulatory class, product code, and indications for use, but not the technical details of its performance validation.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1