Osseofuse International Inc.

Osseofuse International Inc. specializes in dental implant solutions. Their portfolio includes dental implant systems like conical and hexagonal screw-type implants, which are designed to integrate with bone for long-term stability. They also produce dental prosthesis components, such as laboratory abutment analogs and implant abutment screws, which connect prosthetic teeth to the implants. Additionally, they offer sinus-specific implants for patients requiring bone augmentation before implant placement.

Osseofuse International Inc. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies their dental implants as Class II, which typically requires premarket notification (510(k)) clearance before commercial distribution, demonstrating substantial equivalence to a legally marketed predicate device.

Osseofuse International Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and patients to verify the identity and history of the devices. Listing in the UDI database is a requirement for Class II devices in the U.S., ensuring compliance with FDA regulations.

Osseofuse International Inc.’s dental implants fall under FDA’s Class II classification. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Class II devices typically require a 510(k) clearance to demonstrate they are substantially equivalent to a legally marketed predicate device before they can be legally marketed in the U.S.

The laboratory abutment analogs produced by Osseofuse International Inc. are used in dental labs to create custom prosthetic crowns or bridges that fit precisely over dental implants. These analogs replicate the exact shape and connection of the implant abutment, allowing technicians to fabricate restorations before they are placed in the patient’s mouth. The implant abutment screws, meanwhile, secure these prosthetic components directly to the implant fixture within the patient’s jaw, ensuring a stable and functional connection for long-term use.