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510(k) Data Aggregation

    K Number
    K983168
    Device Name
    AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200
    Date Cleared
    1998-11-18

    (69 days)

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

    ORA INNOVATIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Avant handpiece will be used by dentists to remove decayed tooth structure, and to cut or alter the shape of teeth so they may be restored to form and function.
    Device Description
    The Avant is a high speed dental handpiece, 132 millimeters long, with a lightly textured finish for enhanced grip. It is a hand-held, channeled instrument that is powered by compressed air that is delivered through a hose to an air channel in the handpiece at 32-40 psi. This impels the turbine in the head of the handpiece to revolve at approximately 375.000 rpm. Other internal channels deliver air and water to the head for cleaning and cooling. The handpiece may contain, as an accessory, an optics device to light the area of operation. Any common dental bur for cutting (not supplied by Ora Innovations) is held in place in the handpiece head by a push-button chuck. The Avant handpiece housing is constructed of a high temperature, medical grade liquid crystal polymer (Vectra A530 by Ticona, Summit, NJ). There are three major parts which are made from metal: a standard turbine (supplied by a manufacturer of dental handpiece turbines), the threaded connector at the back end which attaches to the standard air/water hose in the dental unit, and the internal tubes that carry the chip air and water. These three parts are substantially equivalent to those in the predicate device. Similar to the predicate device, the Avant handpiece must be cleaned and lubricated with a quality commercial dental handpiece cleaner/lubricant. It is supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single unit or in multiples.
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