DentalMonitoring
Dental Monitoring SASDentalMonitoring is a medical software device that uses AI to analyze pictures of a patient's mouth taken via smartphone and proprietary hardware. It helps dental professionals remotely monitor orthodontic treatments by assessing oral hygiene, soft tissue, dental conditions, alignment, and occlusion. It provides 2D and 3D monitoring capabilities to track treatment progress safely and non-invasively.
Intended Use
DentalMonitoring is software using image processing algorithms to analyze pictures of the oral cavity taken via smartphone and proprietary hardware, intended to assist healthcare professionals in remotely monitoring orthodontic treatments and progress for patients over 6 years old.
Technology
DentalMonitoring uses machine learning and neural networks to process intraoral pictures captured by a smartphone app with proprietary retractor and scan box hardware. It offers a Dashboard for healthcare professionals and a mobile app for patients, enabling 2D and 3D monitoring. The AI analyzes images and 3D models assessing various clinical orthodontic parameters.
Performance
Performance testing included standalone AI evaluation, clinical investigation programs evaluating multiple dental and orthodontic parameters with high sensitivity and specificity, and usability studies ensuring safe and effective use by healthcare professionals and patients. Clinical validation covered oral hygiene, tissue state, dental statements, alignment and occlusion metrics. Usability testing demonstrated safe operation with no critical errors.
Device Timeline
- 1
Submission
5/4/2023
1 year - 2
FDA Approval
5/17/2024
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