Bien-Air Dental SA

Bien-Air Dental SA specializes in dental surgical power tools, including pneumatic and motorized handpieces, motorless components, and remotely-driven drilling systems. Their product range also covers dental delivery systems, lubricants for maintaining surgical instruments, and pneumatic hoses for power tools. These devices are designed for dental procedures such as drilling, implantology, and microsurgery.

Bien-Air Dental SA is based in Switzerland. The company focuses on developing and manufacturing dental surgical power tools and related accessories, catering specifically to dental professionals for procedures requiring precision and efficiency.

Bien-Air Dental SA’s devices are listed in multiple regulatory databases, including the EUDAMED database for European Union compliance, the FDA’s 510(k) premarket notifications registry in the United States, and the FDA’s Unique Device Identifier (UDI) registry. These listings help ensure traceability and regulatory transparency for their products.

Bien-Air Dental SA’s devices are classified as either Class I or Class IIa under EU and FDA regulations. Class I devices generally pose minimal risk and require basic compliance measures, while Class IIa devices involve a moderate level of risk and require additional validation to ensure safety and performance, such as through clinical evaluations or performance testing.