Biotem Co., ltd

Biotem Co., Ltd manufactures dental implant systems, including components designed for osseointegration in oral and maxillofacial applications. Their portfolio also includes bone pins, which are used for internal fixation in surgical procedures. The devices are intended for use in dental and orthopedic settings, supporting structural stability and integration with bone tissue.

The company’s products are regulated under the FDA’s classification system, with devices falling into Class I and Class II categories. These are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations. The manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.