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510(k) Data Aggregation

    K Number
    K972375
    Device Name
    IMPACT AIR 45 HANDPIECE FOR ENDODONTIC USE
    Manufacturer
    GLENWOOD, LLC.
    Date Cleared
    1997-09-10

    (77 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLENWOOD, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used.
    Device Description
    The Impact Air 45 Handpiece for Endodontic Use is an air-powered dental handpiece intended for use in apicoectomy (root canal drainage) and other endodontic procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access. The device is intended for use with all friction-grip burs, including surgical length burs, that conform to I.S.O. and A.D.A. shank diameter standards (0.0626 to 0.0630 inches). The 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. The use of sterile water is recommended. 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 air exits the device principally through an air exhaust tube in the handle. A smaller portion of the air exits through the top of the head of the device. Virtually no air exits from the front of the head into the area of 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.
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    K Number
    K972376
    Device Name
    IMPACT AIR 45 HANDPIECE FOR PERIODONTAL USE
    Manufacturer
    GLENWOOD, LLC.
    Date Cleared
    1997-09-10

    (77 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    GLENWOOD, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Impact Air 45 Handpiece for Periodontal Use is an air-powered dental handpiece intended for use in osteoplasty (bony contouring), odontoplasty, root resection, and other periodontal procedures for which a conventional handpiece would be used.
    Device Description
    The Impact Air 45 Handpiece for Periodontal Use is an air-powered dental handpiece intended for use in osteoplasty (bony contouring), odontoplasty, root resection, and other periodontal procedures for which a conventional handpiece would be used. The handpiece is intended to provide a better work environment than a conventional high-speed, air-powered handpiece in that (1) it is designed so that air is not directed onto the area of the bur and (2) it is designed with a 45-degree back-angled head shank to facilitate access. The device is intended for use with all friction-qrip burs, including surqical length burs, that conform to I.S.O. and A.D.A. shank diameter standards (0.0626 to 0.0630 inches). The 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. The use of sterile water is recommended. 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 air exits the device principally through an air exhaust tube in extes the device portion of the air exits through the the handro. Ear and of the device. Virtually no air exits from the front of the head into the area of the bur. The Impact Air 45 can be sterilized by autoclave when prorne impact in inutes at 250 degrees. Data indicate that after 250 sterilization cycles the handpiece continues to function appropriately.
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