ROOTT AG

ROOTT AG specialises in dental implants, including cylindrical (ROOTT K) and buttress-shaped (ROOTT BS) designs. These implants vary in diameter and length, such as the ROOTT K (7.5 mm × 12 mm or 4.0 mm × 18 mm) and ROOTT BS (3.5 mm × 12 mm). They are designed for osseointegrated fixation in oral and maxillofacial applications, meaning they integrate with bone tissue to support dental restorations.

ROOTT AG is headquartered in Switzerland (CH). Since its devices fall under the scope of the EU Medical Device Regulation (MDR), they are subject to European Union regulatory requirements, including registration in the EUDAMED database.

ROOTT AG’s devices are registered in the EUDAMED database, which is the official European Union database for medical devices. This registry tracks information about manufacturers, devices, and their regulatory status under the EU Medical Device Regulation.

ROOTT AG’s dental implants are classified as Class IIb devices under the EU Medical Device Regulation. This classification applies because dental implants pose a moderate to high risk—requiring rigorous design controls, clinical evaluations, and conformity assessments to ensure safety and performance before market placement.