AlgOss Biotechnologies GmbH

AlgOss Biotechnologies GmbH specializes in synthetic dental bone matrix implants. These devices are designed specifically for bone regeneration in oral and maxillofacial procedures, such as dental implant sites and periodontal defects. The implants act as a resorbable scaffold to support guided bone healing, ensuring integration with natural bone tissue over time.

AlgOss Biotechnologies GmbH is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites may vary.

AlgOss Biotechnologies GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorised for commercial distribution in the United States, helping healthcare providers and regulators identify and verify the devices.

AlgOss Biotechnologies GmbH’s synthetic dental bone matrix implants fall under FDA Class II classification. This classification is assigned based on the device’s intended use and risk level, requiring special controls in addition to general controls to ensure safety and effectiveness. Class II devices undergo a premarket notification (510(k)) process to demonstrate substantial equivalence to a predicate device.