B&W Srl

B&W Srl specializes in dental implant solutions, specifically the B&W Dental Implant System. This system is designed for osseointegrated tooth replacement in oral and maxillofacial applications, helping patients restore function and aesthetics in missing tooth scenarios.

B&W Srl is based in the United States, which means its devices are subject to FDA regulations. The company’s dental implant system falls under FDA’s Class II classification, indicating a moderate level of risk that requires premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device.

The B&W Dental Implant System is listed in the FDA’s 510(k) registry, which tracks devices that have undergone the premarket notification process. This pathway ensures the device meets FDA safety and effectiveness requirements before commercial distribution in the U.S.

The B&W Dental Implant System is classified as a Class II device by the FDA. This classification is based on the device’s intended use and associated risk level. Class II devices require special controls beyond general controls to ensure their safety and performance, such as the 510(k) submission process.