Varios Combi Pro2

The Varios Combi Pro2 is a dental hygiene system that combines ultrasonic scaling and powder polishing capabilities in a single unit. It is used for removing plaque, calculus, and stains from teeth and dental restorations, as well as for root canal preparation and tooth surface cleaning.

The device differs from the predicate (EMS AIRFLOW Prophylaxis Master) in output specifications, patient contact materials, touch display adoption, and wireless foot control via Bluetooth connectivity. These modifications reflect user convenience and market strategy but do not alter the fundamental ultrasonic scaling and air-polishing technology shared with the predicate.

ISO 18397 (powered scaler), ISO 20608 (powder jet handpieces), ISO 17664-1 and 17664-2 (medical device processing information), ISO 17665-1 (sterilization), IEC 62304 (medical device software), IEC 60601 series (medical electrical equipment safety), and ISO 10993-1 (biological evaluation).

The Varios Combi Pro2 is substantially equivalent because it uses the same fundamental ultrasonic and powder-spray technology as the predicate device, operates on identical principles, and performs the same intended uses. Differences in output specifications, display features, and wireless control are minor modifications that do not raise new safety or effectiveness questions and have been verified through compliance testing with recognized standards.