Imetric 4D Imaging Sarl

Imetric 4D Imaging Sarl specializes in dental devices, including dental implant abutment analogs—both for intraoral scanning (reusable) and laboratory use—as well as chairside CAD/CAM milling systems. These products support digital dentistry workflows, from scanning to precise fabrication of dental restorations.

The company is headquartered in Switzerland, which places its devices under the EU Medical Device Regulations (MDR) framework. Since its products are listed in EUDAMED and the FDA’s UDI system, they are also relevant to the US market, though regulatory compliance depends on individual device classifications (Class I or Class II).

Imetric 4D Imaging Sarl’s devices are included in EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) database, ensuring traceability for both EU and US markets. These listings reflect compliance with respective regulatory requirements for Class I and Class II devices.

Under the EU MDR, Imetric 4D Imaging Sarl’s products fall into Class I (lower-risk devices like reusable intraoral scanning analogs) and Class II (higher-risk devices such as CAD/CAM milling systems). Classification determines regulatory obligations like clinical evaluations, risk management, and post-market surveillance.