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VELMENI for DENTISTS (V4D) is a concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings/restorations, fixed prostheses, and implants in digital bitewing, periapical, and panoramic radiographs of permanent teeth in patients 15 years of age or older. This device provides additional information for dentists in examining radiographs of patients' teeth. This device is not intended as a replacement for a complete examination by the dentist or their clinical judgment that considers other relevant information from the image, patient history, or actual in vivo clinical assessment. Final diagnoses and patient treatment plans are the responsibility of the dentist.

V4D software medical device comprises of the following key components: - Web Application Interface delivers front-end capabilities and is the point of interaction between the device and the user. - Machine Learning (ML) Engine delivers V4D's core ML capabilities through the radiograph type classifier, condition detection module, tooth numbering module, and merging module. - Backend API allows interaction between all the components, as defined in this section, in order to fulfill the user's requests on the web application interface. - Queue receives and stores messages from Backend API to send to Al-Worker. - Al-Worker accepts radiograph analysis requests from Backend API via the Queue, passes gray scale radiographs to the ML Engine in the supported extensions (jpeg and png), and returns the ML analysis results to the Backend API. - Database and File Storage store critical information related to the application, including user data, patient profiles, analysis results, radiographs, and associated data. The following non-medical interfaces are also available with VELMENI for DENTISTS (V4D): - VELMENI BRIDGE (VB) acts as a conduit enabling data and information exchange between Backend API and third-party software like Patient Management or Imaging Software - Rejection Review (RR) module captures the ML-detected conditions rejected by dental professionals to aid in future product development and to be evaluated in accordance with VELMENIs post-market surveillance procedure.