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510(k) Data Aggregation

    K Number
    K153710
    Device Name
    Tuxedo Digital Dental Sensor
    Manufacturer
    Date Cleared
    2016-03-18

    (85 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED DENTAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Tuxedo Digital Dental Sensor is a CMOS sensor for the capturing of digital diagnostic x-ray images on a patient for evaluation by an appropriately trained oral healthcare professional.
    Device Description
    The TUXEDO Dental Digital Sensor is used in the detection and diagnosis of anomalies in dental anatomy, as well as for the evaluation of performed treatment in dental care. The primary use is by general dental practitioners to detect the presence and extent of carious legions in the dentin and enamel of a tooth. Two different sized sensors (size 1 and size 2) are utilized to image different anatomy and different patient sizes. The TUXEDO Dental Digital Sensor functions by being placed in a patient's mouth lingually by a licensed dental practitioner, and is designed to capture collimated radiation which is converted into a digital image for viewing by a licensed dental practitioner. The capturing of the radiation is done within the TUXEDO sensor casing which contains a scintillator used to convert the radiation into visible light, and this visible light is immediately captured by the internal CMOS sensor. The digital image is transferred to a computer via USB 2.0 and can be viewed in most common imaging software programs, including LED Imaging Software. A software driver is available from LED Dental which will allow the TUXEDO sensor to be used in these software programs. The software supplied with the Tuxedo Digital Dental Sensor was cleared separately by FDA by Apteryx, Inc. The sensor is intended to be used with a disposable barrier sheath that should be replaced between patients. This is to reduce cross contamination between patients. The sensor is also sealed in a way that the portion of the device that is placed in the patient's mouth can be sterilized with liquid without the device being damaged.
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    K Number
    K102083
    Device Name
    VELSCOPE VX
    Manufacturer
    Date Cleared
    2010-11-18

    (115 days)

    Product Code
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED DENTAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VELscope Vx is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer and premalignant dysplasia. VELscope Vx is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
    Device Description
    The VELscope Vx system is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination. The main components of VELscope are the Handpiece, incorporating light source, viewing optics and rechargeable battery. Charging Cradle and external power supply. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, abnormal tissue typically appears as an irregular, dark area that stands out against the otherwise normal green fluorescence pattern of surrounding health tissue.
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    K Number
    K070523
    Device Name
    MODIFICATION TO: VELSCOPE
    Manufacturer
    Date Cleared
    2007-04-05

    (41 days)

    Product Code
    Regulation Number
    872.6350
    Why did this record match?
    Applicant Name (Manufacturer) :

    LED DENTAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    VELscope is intended to be used by a dentist or health-care provider as an adjunct to traditional oral examination by incandescent light to enhance the visualization of oral mucosal abnormalities that may not be apparent or visible to the naked eye, such as oral cancer or premalignant dysplasia. VELscope is further intended to be used by a surgeon to help identify diseased tissue around a clinically apparent lesion and thus aid in determining the appropriate margin for surgical excision.
    Device Description
    VELscope is a natural tissue fluorescence direct visualization system to be used as an adjunctive tool for oral mucosal examination. The main components of VELscope are the Light Source Unit (LSU) and the viewing Handpiece. The VELscope Handpiece emits a safe, visible, blue light into the oral cavity, which excites the oral tissue and causes it to fluoresce. The oral cavity can then be examined in real time and suspicious tissue that may require further investigation can be quickly identified. When viewed through the VELscope Handpiece, healthy tissue typically shows up as a brighter green color while suspicious tissue can cause a loss of fluorescence, which thus appears dark.
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