Dentaleye AB

Dentaleye AB specializes in radiological Picture Archiving and Communication Systems (PACS) software tailored for dental imaging. Their primary focus is on the DentalEye software system, which falls under radiological PACS solutions. This type of software enables dental practices to store, retrieve, and manage digital dental X-ray images efficiently.

Dentaleye AB is based in the US, which means its devices are subject to US regulatory requirements. Since their products are classified as Class II medical devices, they are regulated by the FDA under the authority of the Federal Food, Drug, and Cosmetic Act. This classification indicates moderate risk, requiring compliance with specific controls to ensure safety and effectiveness.

Yes, Dentaleye AB’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency in the medical device supply chain, allowing healthcare providers, regulators, and other stakeholders to verify product details, such as device identification, manufacturing information, and compliance status. Listing in the UDI database is a requirement for Class II devices in the US.

Dentaleye AB’s devices are classified as Class II under FDA regulations. This classification is assigned based on the level of risk associated with the device. Class II devices generally pose moderate risk and require special controls in addition to general controls to ensure their safety and performance. These controls may include performance standards, post-market surveillance, or labeling requirements.