Dental Monitoring SAS

Dental Monitoring SAS produces intraoral scanners like the ScanBox pro, which capture digital dental impressions for orthodontic and restorative treatments. It also makes LED adapters to improve imaging quality and the DM Cheek Retractor, a device that helps position a patient’s cheek during scans. Additionally, the company offers a software platform called DentalMonitoring for orthodontic monitoring and treatment planning.

Dental Monitoring SAS is based in France. The company’s headquarters and operations are located within the country, which is relevant for regulatory compliance and device classification under EU Medical Device Regulations.

All of Dental Monitoring SAS’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is maintained by the European Commission to ensure transparency and traceability of devices under the EU Medical Device Regulations.

Dental Monitoring SAS’s devices are classified as Class I and Class IIa under the EU Medical Device Regulations. This classification depends on factors like the device’s intended use, risk level, and interaction with the body. For example, intraoral scanners like the ScanBox pro are typically lower-risk (Class I), while software platforms or accessories with higher clinical involvement may fall into Class IIa.

The classification determines the regulatory requirements for each device, including conformity assessment procedures, labeling obligations, and post-market surveillance needs. For instance, Class I devices generally require less stringent scrutiny than Class IIa devices, which may need additional clinical evaluations or involvement from a Notified Body. This ensures appropriate oversight based on the device’s risk profile.