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510(k) Data Aggregation

    K Number
    K991011
    Device Name
    ORASCOPE
    Manufacturer
    FIBERDENT CORP.
    Date Cleared
    1999-06-23

    (89 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    FIBERDENT CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FiberDent Corporation Orascope™ is a non-diagnostic fiberoptic visualization device used to illuminate and magnify dental surfaces.
    Device Description
    The Orascope consists of a flexible fiberoptic probe with sterile disposable sheath. The probe feeds magnified images from within the oral cavity. The flexible fiberoptic probe transmits the image information and light to and from the oral cavity. A light source transmits light through the fiber to illuminate the target area. Real time image information from the target area is transmitted through the fiber to a CCD color camera which sends this information to the flat screen display monitor to be viewed by the user. The flat screen display is mounted on a wheeled flexible stand which can be positioned for optimum viewing comfort. The Orascope enhances the dentist's ability to see within the oral cavity. The Orascope consists of the fiberoptic endoscope and sterile disposable sheath. A digital camera, monitor and video printer are also offered as accessories to the Orascope. Orascope Fiberoptic Dental Endoscopes: The Orascope consists of a flexible fiberoptic probe which contains both lightemitting fibers and image transmission fibers. The light emitting fibers gather light from a high-intensity light source affixed to the wheeled display stand. The light shines out the probe tip to illuminate the field-of-view for the image transmission fibers. The image transmission fibers transmit the image from the end of the probe tip back to the wheeled display stand where the color video camera creates the electronic image for display on the display screen. The Orascope is offered in both 0.9 mm and 1.8 mm tip outer diameter sizes. Each probe contains light conducting fibers for the illumination of the probe's field-of-view as well as image conducting fibers for optical transmission of the image of the field-of-view to the camera. Sterile Disposable Sheath: The sterile disposable sheath is a single use closed end sheath which covers the end of the probe for about 100 mm. This sheath has been subjected to USP Class VI biocompatibility test results and cytotoxicity testing. Viral Penetration testing has been performed on the sheaths. The test results showed that virus (bacteriophagy) did not penetrate the film or the heat seals of the sheaths tested. Camera: The camera offered with the Orascope is a Panasonic GP-US522 three-chip color CCD camera with remote head. The GP-US522 is a standard three-chip color CCD camera with a resolution of 768 (H) x 494 (V). The camera operates on 12 VDC. The camera is used to capture a video image from the Orascope fiber-optic probe(s) and provide an S-Video signal for display by the video monitor. Video Monitor: The video monitor offered with the Orascope is a National Display Systems 15" XGA Flat Panel Video Display Monitor Model #DSW-X15-N. This flat-screen video display monitor operates from the S-Video signal provided by the camera. The monitor operates on 12 VDC. Light Source: The light source is a Cuda Products Corporation dual channel Xenon-quality fiberoptic light source. The MX2-300 operates on 120 VAC and provides illumination from one of two metal-halide bulbs. Dual channel means that the light source contains two bulbs. If one bulb burns out during a procedure, the light source can be configured so that the second bulb can be used within seconds. The light from the bulb is reflected onto a fiberoptic light-guide which is plugged into the cable receptacle on the front of the MX2-300.
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