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510(k) Data Aggregation

    K Number
    K070535
    Device Name
    RETROPAN CCD-TWAIN-USB
    Date Cleared
    2007-04-24

    (57 days)

    Product Code
    Regulation Number
    872.1800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIDEO DENTAL CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The RetroPan CCD -- TWAIN - USB Digital X-ray Conversion Kit from Video Dental Concepts, Inc. is used to provide instant x-ray images of human oral tissue and teeth without the use of conventional x-ray films. The RetroPan CCD - TWAIN - USB sensor produces instant digital images. The RetroPan CCD - TWAIN - USB allows the use of less exposure time than with conventional films, thus lowering patient dose. The sensor is connected to the DentalEye software, #K-12439, which gives post processing capabilities to enhance images. It is faster to obtain images with the RetroPan CCD – TWAIN – USB Retrofit Kit than from conventional film since no chemical nor any other type of processing is required.
    Device Description
    The RetroPan CCD - TWAIN - USB Digital X-ray Conversion Kit is a sensor connected to the DentalEye software, #K-12439.
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    K Number
    K020957
    Device Name
    ORACAM
    Date Cleared
    2002-06-13

    (80 days)

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

    VIDEO DENTAL CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The OraCam is used to provide Intra oral images of the human mouth and teeth, allowing brilliant, sharp images with larger-than-life pictorial accuracy allowing the dentist to examine patient's teeth in order for them to adequately plan in the treatment. The OraCam is therefore similar in indicated use as Stomavision, Vipercam, Telicam, Digital Doc, S555 and S575, MiniCam and Smilie PC systems, in its intended use.
    Device Description
    Not Found
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    K Number
    K001541
    Device Name
    MINICAM
    Date Cleared
    2000-07-21

    (65 days)

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

    VIDEO DENTAL CONCEPTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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