Nobel Biocare AB

Nobel Biocare AB specializes in dental implant-related devices, focusing on single-use components. Their portfolio includes temporary preformed dental implant suprastructures like screwdrivers, try-in screws, and replica implants used for prosthetic fitting. Additionally, they produce carbide dental burs for one-time use in dental procedures, as well as guided components such as base replicas, protection analogs, and guide pins for implant placement and verification.

Nobel Biocare AB is headquartered in Sweden, which means their devices are subject to EU Medical Device Regulations (MDR). Since they manufacture products listed under Class I, Class IIa, and Class IIb, their devices must comply with these regulations and are registered in the EUDAMED database, the official EU registry for medical devices.

Nobel Biocare AB’s devices are listed in the EUDAMED database, the European Union’s central registry for medical devices. This registry ensures transparency and traceability of devices under the EU Medical Device Regulations, allowing healthcare professionals, regulators, and patients to verify the legal status and classification of their products.

Nobel Biocare AB’s devices fall under Class I, Class IIa, and Class IIb classifications under the EU Medical Device Regulations. This classification determines the level of scrutiny and regulatory requirements for each product—Class I devices are generally low-risk, while Class IIa and IIb involve higher risks and require additional safety and performance evaluations before authorization.