Josef Ganter Feinmechanik GmbH

Josef Ganter Feinmechanik GmbH specializes in dental torque wrenches and adaptors. These devices are designed for precise torque control during dental implant procedures, ensuring consistent and accurate tightening of components. Examples include manual torque wrenches like the NobelPearl Manual Torque Wrench, torque ratchets, and specialized adaptors such as the Zeramex Surgical Ratchet and NobelPearl Manual Torque Wrench Adapter.

The company is based in the United States. Its devices are regulated under U.S. jurisdiction, specifically under FDA guidelines. The portfolio includes products intended for dental applications, where regulatory compliance ensures safety and performance standards are met.

Josef Ganter Feinmechanik GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

The company’s devices fall under Class I classification according to FDA regulations. This classification typically applies to low-risk medical devices, such as dental torque wrenches and adaptors, which pose minimal risk to patients when used as intended. The classification is determined by factors like the device’s purpose, design, and potential risks.