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DentalMonitoring is a medical device software using image processing algorithms to analyze pictures of the oral cavity (hereinafter Scans). Scans are taken using the DM App, a smartphone, and the manufacturer's proprietary hardware products. Scans are taken by the patient, a non-healthcare professional, or a healthcare professional. The Scan is taken in healthcare facilities, such as a dental practice, or in a non-healthcare environment, such as the patient's own home. For some clinical parameters. DentalMonitoring requires a 3D Model. The product is designed to assist healthcare professionals in remotely monitoring orthodontic treatments and treatment progress. The results of DentalMonitoring are intended to be used as an aid in diagnosis and monitoring, not on a stand-alone basis for clinical decision-making. DentalMonitoring is indicated for use for patients over the age of 6 and reports results solely on permanent teeth. DentalMonitoring can monitor the following clinical parameters: - . oral hygiene: dental plaque / food residue; - 트 soft tissue statement: gingival recession, black triangle; - . dental statement: closure of extraction space, tooth wear; - . alignment: closure of all anterior spaces; and - . dental occlusion: - o in 2D Monitoring: midline deviation, overbite/open bite, overjet - o in 3D Monitoring: canine class, midline deviation, overbite/open bite, overjet Additionally, the following clinical parameters specific to orthodontic treatment types or phases can be monitored using DentalMonitoring: - for aligner treatments: tracking (seat/unseat), attachment loss, button loss; . - . for braces: bracket debonding, tie loss, self-ligating clips, passive archwire and auxiliaries; and - for thermoformed retainers: tracking (seat/unseat). I Based on an initial 3D Model provided by a healthcare professional. DentalMonitoring can also provide healthcare professionals with 3D Models representative of the patient's dentition and treatment progress. This device is a prescription device and is not intended for over-the-counter use

DentalMonitoring is a standalone software with embedded artificial intelligence comprising machine learning and locked neural network algorithms. The product is composed of these parts: the Dashboard, the DM App along with a DM Cheek Retractor and DM ScanBox, and the Data Analysis Platform. The four steps are detailed below: - 1. Patient profile set-up: The healthcare professional sets up the patient profile through a web- based interface, Dashboard, accessible at www.dental-monitoring.com/doctor. During the patient profile set-up, the healthcare professional is prompted to set up a Protocol in order to select the clinical parameters they wish to monitor in accordance with the patient's treatment. During the set-up, the healthcare professional also determines the appropriate frequency at which the patient should use the DM App to take pictures of their intraoral cavity. - 2. Intraoral pictures acquisition: A set of pictures of the patient's intraoral cavity, hereinafter referred to as a Scan, is taken using the DM App along with a DM Cheek Retractor and DM ScanBox. The DM Cheek Retractor is an intraoral retraction device for the cheeks and lips to allow for sufficient space for image capture. The DM ScanBox is an extraoral holding apparatus for the smartphone that attaches to the DM Cheek Retractor. The DM App guides the user through the appropriate steps in order to obtain a complete Scan. This DM App is a mobile application installed on a smartphone; thus, the pictures are captured through the smartphone's main camera allowing the procedure to be totally non-invasive to the patient. - 3. Analysis of acquired intraoral pictures: The Scan is processed through the Data Analysis Platform. The Data Analysis Platform includes a technical processing phase and clinical processing phase, the latter being a clinical analysis to determine if any event has occurred within the clinical parameters the healthcare professional has set up to be monitored. The Data Analysis Platform uses AI comprising image processing algorithms and neural networks. - 4. Communication of results of the analysis performed through the Data Analysis Platform are communicated to the healthcare professional through the Dashboard on one hand, and to the patient through the DM App on the other hand. Results are shared with the healthcare professional in an exhaustive fashion, providing them with detailed information. As for the patient, the results are communicated in accordance with the rules defined by the healthcare professional in the Protocol applied to the patient. DentalMonitoring enables HCPs to adapt the use of the product according to their needs depending on each patient's orthodontic treatment. DentalMonitoring comprises two types of monitoring: 2D Monitoring and 3D Monitoring. Some clinical parameters are specific to either 2D Monitoring, or 3D Monitoring.