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The iTero Lumina Pro NRI functionality is a diagnostic aid for the detection of interproximal carious lesions above the gingiva and for monitoring the progress of such lesions.

The iTero Lumina Pro is an integrated intraoral imaging system capable of capturing 3D optical impressions for CAD/CAM of dental devices, 2D color images and Near Infrared (NIR) images. Scanning cycles are employed allowing the system to quickly alternate between the three modalities, creating a virtually simultaneous capture of the 3D optical impression, 2D color and NIR images. The iTero Lumina Pro consists of the following main components: - A. Scanning Wand used for intraoral scanning. - B. Wand Cradle used to hold the Scanning Wand when not in use. - C. Application Software that includes Graphical User Interface ("GUI"). - D. Computer platform The scanning wand houses electronic, mechanical, and optical components, including projectors, LEDs and cameras which enables capturing 3D impression data as well as 2D color and NIRI images. The wand body is made of Aluminum, Copolyester and Glass. When not in use, it is stored in the Wand Cradle. The iTero Lumina Pro features proprietary software that can be installed on the various configurations of the computer platform. The software is designed to manage the GUI, control the scanning process, display the scanned images, and connect to the stored patient data, including scanned data for display or export. The iTero Lumina scanning wand is designed to be used with a single-use, non-sterile, disposable, wand barrier sleeve. The only patient-contacting materials are those contained within the wand barrier sleeve.

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.

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.

The iTero Element 5D is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

The iTero Element 5D is an integrated intraoral imaging system capable of 3D confocal optical impressions for CAD/CAM of dental devices, which also captures 2D color images and Near Infrared (NIR) images. The iTero Element 5D consists of a scanning wand cradle, single-use, disposable, 5D barrier sleeve, iTero Element 5D Sleeve (protective sleeve), software (including GUI), and a computer hardware platform that is offered in two configurations: 1. Laptop Configuration, where the GUI is presented on a customer-provided PC Laptop Touchscreen; 2. Wheel Stand Configuration where the GUI is presented on a display panel that is mounted on a wheel stand base unit. The scanning wand and software, including the GUI, are common to both configurations. The scanning wand which has 3 imaging capabilities: 1) 3D confocal optical impression, 2) 2D color imaging and 3) near infrared imaging (NIRI), is designed to be used with a single-use, disposable, scanning wand barrier sleeve ("5D barrier sleeve") during scans and a protective sleeve during storage. At the beginning of every scan, the single-use, disposable, 5D barrier sleeve is placed on the scanning wand's head. The wand tip is placed slightly above the patient's teeth and the scan is initiated. At the end of the scan, proprietary imaging software converts the scan into an image that is simultaneously presented alongside the 2D color images on the GUI display. The 3D confocal optical impression and 2D color images assist in orientation by providing an enhanced view of the scanned teeth, thus helping the user identify which areas (i.e. occlusal direction/angles) to view as NIR images. The 2D color image displays a close-up view of the teeth while the NIR Image translates the teeth structure (enamel and dentin) to different brightness levels.

The DEXIS CariVu 3-in-1 by KaVo acquires patient images as a diagnostic aid for detection of smooth surface caries, occlusal caries, proximal caries, secondary caries, and tooth cracks. The DEXIS Cari Vu 3-in-1 by KaVo is designed for use by a trained professional in the field of dentistry.

The device is used as an intraoral camera to acquire images in the oral cavity of the patient. The camera combines three different known applications from available intraoral cameras in one device. These applications are standard camera functionality, transillumination and fluorescence caries detection. Therefore, the camera uses different light colors for each of the three applications to illuminate the tooth. In combination with an optical system, CMOS sensor, and an internal image processing unit, a digital image of the tooth is generated. The live images are transferred as a standard mjpg video stream via USB interface to a running computer and can interface with a dental imaging software such as for example CONEXIO for basic intraoral camera management functionality. The device may be used as an aid for monitoring caries lesion size and shape by comparing images taken with the Dexis CariVu 3-in-1 by KaVo over time, by using different reference points, such as tooth contour and position the device to optimize capturing tooth features previously recorded in a still or video image. For easy use the camera is equipped with an autofocus mechanism which will provide a sharp representation of the tooth which is placed in the center of the imaqe. The autofocus provides the ability to have sharp images from close distances of about 2mm to about 120mm distance. The different operation modes are described as follows: 1.) Color mode: For normal color images, a white LED for illumination is used. With this light the camera provides coloured images or videos. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. 2. Fluorescence mode: For the fluorescence mode the blue LED illumination is used. The blue light excites bacterial porphorines as an aid to detect caries. To enhance the image quality and to minimize external light influence on the fluorescence effect the accessories Fluorescence Cover Vision Full HD can be used optionally with the camera. The Fluorescence Cover Vision Full HD is a rubber cap which can be slipped on the front camera head and prevent or minimize external light on the images surface of the tooth. After each usaqe the Fluorescence Cover Vision Full HD will be reprocessed separately. The camera can be used with or without a Tip Vision Full HD which is required for illumination for the transillumination mode. This mode is used to record images and videos to aid in the diagnosis of caries (mainly in the occlusal area) and plaque by means of fluorescent effect. 3. Transillumination mode (by the use of near infrared light): The transillumination mode provides images to aid in the detection of caries. For this mode near infrared light will be used. The near infrared light penetrates the side of the tooth near gingiva and illuminates the enamel of the tooth to produce gray scale images whereby intact enamel appears bright, and defects such as caries or cracks result in diffusion of light path and create an area of dark appearance. To use this mode, the Tip Vision Full HD must be attached to the device as the LEDs for the illumination are located inside the Tip Vision Full HD. The Tip Vision Full HD touches the side of the tooth and gingiva and illuminates it from two sides whereas the image is taken from the top. The DEXIS CariVu 3-in-1 by KaVo is available in two similar models. The differences between the models are a wall mounted version to store the device with a cable length of 2.5 meters (model 1.011.4444) and a table holder version to store the device on a dental unit with a cable length of 1.55 meters (model 1.013.1700). All critical components within the DEXIS CariVu 3in-1 by KaVo are common. A disposable sheath is used with the device to mitigate the potential for cross contamination.

The CamX Triton HD Proxi Head is a diagnostic aid for the detection of interproximal caries lesions above the gingiva and for monitoring the progress of such lesions.

The CamX Triton HD "Proxi" aids in the detection and diagnosis of proximal caries. It consists of a toothbrush-sized handpiece and a "Proxi" head. A USB cable connects the handpiece to a personal computer with PACS software such as DBSWIN to enable communication between a PC computer and the handpiece. After a camera cover (single patient disposable sheath, K132953) is placed over the distal end, and an autoclave-able spacer is installed, the Handpiece is positioned over the teeth to be examined. The camera functions by transilluminating sound tooth enamel with infrared light. Areas that spread and reflect the light (e.g. caries lesions) show up clearly delimited bright areas. A digital camera converts the object situation into an electrical signal, sent it over USB to a computer, converted into an image (by imaging software) and presented on a monitor in monochrome colors to illustrate suspected areas of decay.

The DIAGNOcam 2170 Is a diagnostic ald for the detection of open or includent carles lesions above the gingiva and for monitoring the progress of such lesions. Indications: - Detection of smooth surface caries - Detection of occlusal carries - Detection of proximal carles - Detection of Initial caries - Detection of secondary caries - Detection of cracks

The DIAGNOcam 2170 is a handheld laser fluorescence caries detection device which uses the DIFOTI technology (Digital Imaging Fiberoptic Transillumination) as the functional principle. KaVo DIAGNOcam 2170 delivers images, which are reminiscent of X-rays but which are completely radiation free - by means of a light that is especially adapted to this examination method. The tooth structures allow the passage of light from the entry site to the camera. Areas that block light transmission (e.g. carious lesions) show up clearly as well delimited, dark areas. A digital camera captures the actual situation and makes it visible in real-time on the screen. The USB connector provides electric power to the unit. The DIAGNOcam 2170 will be delivered with a firmware (unit) at the handheld device which is responsible for steering of the camera functions and a computer based software (image) which is responsible to show / display the pictures, store / save the pictures and the possibility of a life stream. The internal laser diode generates an exact wavelength being detectable by the CCD sensor. The DIAGNOcam 2170 follows the international standards for electrical safety and electromagnetic compatibility which are applicable for the use with human beings. The DIAGNOcam 2170 works with a laser wavelength at 788 nm and an output power of 2mW for each laser diode (2 sources). The maximum output power is 21mW/cm2.

The Ti2200 Transillumination Cable is a diagnostic aid used to locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures underneath the tooth surface utilizing a fiber optic cable and handle attached to a light source.

The Ti2200 Transillumination Cable is a fiber optic transilluminator connected directly to a light source. The Ti2200 Transillumination Cable uses a 2.1mm fiber-optic bundle with a 45 degree stainless steel end-tip. The end-tip, when placed on the tooth surface (and when other sources of light are minimized), creates an illuminated tooth structure to help locate decay, calculus, fracture lines, endodontic orifices, cracks and fissures. These clinical entities reduce the ability to transmit light and therefore show up as dark areas in an otherwise bright structure thus aiding in diagnosis.

The Microlux Transilluminator is a device used upon initial examination of the dental patient to help locate crown fractures, posterior and anterior caries. The Microlux Transilluminator is a screening device used to help locate caries and crown fractures. It also functions as an auxiliary light source to aid in operative procedures and preventive dentistry.

The Microlux Transilluminator consists of a battery powered, high output L.E.D. light source, (three 'N" size batteries are included) and a fiber-optic glass light guide with either a 3mm or 2mm tip. The fiber-optic glass light guide snaps into the light source. The fiber-optic light guide is autoclaveable. The light source can be wiped with disinfectant. Disposable custom fitted sleeves are also available the cover the entire unit to prevent cross contamination.

For use as an aid in the detection and localization of subgingival dental calculus.

This submission is for a modification of a device system cleared under K042394, the DIAGNOdent® 2095 with periodontal probe, and Diagnodent Pen, K051909. The modification is in the form of adding a periodontal probe to the Diagnodent Pen product.

The DIFOTI USB 2.0 System (DIFOTI System for Dental Examinations, Model B) is indicated for detection of frank or incipient caries lesions above the gum line, and for monitoring the progression of such lesions.

The device known as the DIFOTI USB 2.0 System, also known as the DIFOTI System for Dental Examinations, Model B, is a dental examination system that utilizes visible light from an internal diode laser source. delivered with fiberoptic technology, for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic (CMOS) camera is used to capture the image(s). The light and the camera are connected via a USB 2.0 cable to a small PC that serves for data acquisition and storage, and the computer monitor is used for image visualization.