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510(k) Data Aggregation

    K Number
    K952927
    Device Name
    IMPACT AIR 45 4-HOLE
    Manufacturer
    PALISADES PHARMACEUTICS, INC.
    Date Cleared
    1996-08-06

    (407 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMPACT AIR 45 4-HOLE

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

    Not Found

    Device Description

    The Impact Air 45 Handpiece is an air-powered dental handpiece. The handpiece has an angled head shank with a back angle of 45 degrees. It is intended for use with all friction-grip bur that conform to I.S.O. and A.D.A. recommended operating air pressure is between 32 and 40 pounds per square inch ("psi"), which results in high-speed bur rotation (approximately 400,000 to 500,000 revolutions per minute ("rpm")). The device includes a water line that directs water onto the spinning bur, which forms a cooling mist and also helps irrigate the working area. One model of the device also includes a fiberoptic bundle that directs light onto the working area.

    The device may be connected to a standard compressed air source found in virtually all dental units. The use of filtered air is recommended. The air supply enters the device through a tube in the handle and turns the turbine, which is in the head of the device, thus spinning the bur.

    The Impact air 45 can be sterilized by autoclave when processed for 35 minutes at 250 degrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.

    AI/ML Overview

    The provided text describes a 510(k) summary for a dental handpiece, focusing on its substantial equivalence to a predicate device and its characteristics. It does NOT contain information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

    Therefore, I cannot provide the requested table and information based on the given text. The text only mentions:

    • Device: Impact Air 45 Handpiece
    • Intended Use: For use with friction-grip burs that conform to I.S.O. and A.D.A. standards, operating at high speeds (400,000-500,000 rpm) with water cooling and optional fiberoptic lighting.
    • Sterilization: Autoclavable for 35 minutes at 250 degrees, maintaining function after 250 sterilization cycles.
    • Predicate Device: Midwest Quiet Air Handpiece
    • Substantial Equivalence: Claimed based on similar intended use, safety/effectiveness, operating principle, design, materials, and energy source.
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