Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K213482
    Device Name
    TIA Tip, Cariosity, Transillumination Accessory Tip
    Manufacturer
    D4D Technologies, LLC
    Date Cleared
    2022-04-29

    (182 days)

    Product Code
    NTK
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    D4D Technologies, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TIA Tip is a diagnostic aid for viewing the interproximal areas of dental anatomy to detect and monitor the progression of proximal carious lesions above the gingiva.
    Device Description
    The TIA Tip is an optional interchangeable component tip assembly that works with the Dental CAD/CAM System Scanner. With the TIA Tip installed the system allows for the simultaneous side by side visualization of live transilluminated and color imaging of the patient's dental anatomy, as well as providing the user with the ability to capture and save transilluminated static images to a patient digital file. The system consists of: - Dental Scanner . - TIA Tip ● - Computer with Software ● With one of the other provided interchangeable scanning tips installed, the system is also used to process dental restorations that are regulated under 21 CFR 872.3661, Optical Impression Systems for CAD/CAM of Dental Restorations. The Scanner is a hand-held electronic device that consists of three parts: the scanner body, the TIA Tip and a custom USB data cable that connects the scanner to the computer. The scanner contains the electrical and opto-mechanical components. The USB cable uses industry standard USB 3.0 type-A and type-C connectors, and the cable assembly is detachable making it easily replaceable. The TIA tip must be connected to the scanner to work. It incorporates two "probes" containing Light Emitting Diodes (LEDs) that emit 727nm near infrared light. In operation the probes conform to dental anatomy to direct light into the desired area of inspection. The light penetrates the tooth surface due to the translucent nature of dental anatomy. This allows a user to visualize the inner structure of the tooth and specifically to detect irreqularities like caries that show up as dark areas or spots on the transilluminated image. The scattering light of the illuminated anatomy is reflected by the tip mirror and directed toward the camera in the scanner which allows for a digital image to be captured. The tooth is illuminated with light from both the scanner's laser projection system (RGB) and the TIA Tip LED's. Timing of the light is controlled through the electronics and is divided into separate frames. Collecting and presenting these images at many frames per second allows simultaneous "live" views of transilluminated image and full color view to the system operator. This allows the user to better visualize caries that cannot be detected with standard color imaging. For example, a proximal dental cavity becomes visible as a dark region in the transilluminated image. The software will also allow for the capture of static images throughout the inspection process if the user wishes to document an area of interest and show the patient to discuss treatment options. The software operates on a laptop or desktop pc. A network connection is required for interoperability. When the TIA Tip is installed, it is automatically detected by the scanner and the operator is presented with both a transilluminated view and a live view simultaneously. The operator is provided with controls on the scanner to start/stop and toggle TIA illumination from Both/Right/Left LEDs to enhance TIA viewing. Additionally, on screen controls allow for TIA illumination intensity control for further TIA view optimization. Image capture of simultaneous TIA and live view images is provided which can be used for later reference. No digitization occurs during TIA viewing.
    Ask a Question

    Page 1 of 1