Implantech Associates, Inc.

Implantech Associates, Inc. specializes in silicone-based reconstructive materials and prostheses. Their devices include facial prostheses like chin, nasal cartilage support, malar, and mandibular implants, as well as external ear prostheses. They also produce reusable scar-management dressings and non-sterile silicone sheets for tissue reconstruction. Many of their products are customizable silicone blocks or pre-shaped implants designed for surgical use in head and neck reconstruction.

Implantech Associates, Inc. is headquartered in the United States. Because of this, their devices are listed in the FDA’s Unique Device Identifier (UDI) system, which is a requirement for U.S.-based manufacturers. Additionally, their devices appear in the EU’s eudamed database, indicating they are also marketed or intended for use in the European Economic Area, where eudamed registration is mandatory for medical devices.

Implantech Associates, Inc.’s devices are listed in two key regulatory registries: the FDA’s Unique Device Identifier (UDI) system and the EU’s eudamed database. The UDI listing is required for devices marketed in the U.S. under FDA regulations, ensuring traceability and compliance. The eudamed listing is mandatory for devices placed on the EU market, as it facilitates transparency and regulatory oversight in the European Economic Area.

Implantech Associates, Inc.’s devices fall into three FDA classification categories: Class I, Class II, and Class IIb. Class I devices generally pose the lowest risk and may have fewer regulatory controls, while Class II devices require special controls to ensure safety and effectiveness. Class IIb devices are more complex and carry higher risks, necessitating stricter regulatory scrutiny. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, as outlined in FDA’s regulatory framework.