Biotem Co., ltd

Biotem Co., Ltd specializes in dental implant systems, which are designed to integrate with bone tissue for oral and maxillofacial applications. Their portfolio also includes bone pins, which are used in surgical procedures for internal fixation to stabilize bone structures. These devices are intended for use in both dental and orthopedic settings.

Biotem Co., Ltd is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification under the FDA’s system. This ensures compliance with U.S. medical device requirements and traceability through the FDA’s Unique Device Identifier (UDI) database.

Biotem Co., Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides a standardized way to track and identify medical devices, ensuring transparency, traceability, and compliance with U.S. regulatory requirements for device safety and performance.

Biotem Co., Ltd’s devices are classified as either Class I or Class II under the FDA’s regulatory framework. Class I devices generally pose the lowest risk and may require less stringent controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. Classification determines the regulatory pathway and oversight required for each device type.