Osstem Implant Co., Ltd._Gasan Branch

Osstem Implant Co., Ltd. specializes in dental devices, including screw-type dental implant systems for tooth replacement, line-powered dental handpieces for surgical procedures, and portable digital X-ray systems for intraoral and extraoral diagnostic imaging. These products are designed to support dental diagnostics, restorative treatments, and surgical workflows.

Osstem Implant Co., Ltd. operates from a branch in the United States, though its parent company is based in South Korea. The company’s U.S.-based branch ensures its devices comply with FDA regulations, as the FDA oversees medical devices marketed in the U.S. This includes classification under FDA’s Class II category, which applies to devices requiring special controls to ensure safety and effectiveness.

Osstem Implant Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and market surveillance purposes. This listing is mandatory for Class II devices marketed in the U.S.

Osstem Implant Co., Ltd.’s devices fall under FDA’s Class II classification. This classification is assigned based on the level of risk and regulatory controls required. Class II devices, like dental implants and X-ray systems, typically require special controls beyond general controls (e.g., performance standards, post-market surveillance) to mitigate moderate risks while balancing innovation and accessibility.

Healthcare providers may verify Osstem Implant Co., Ltd.’s devices in the FDA’s UDI database to confirm their legitimacy, compliance status, and regulatory history before use. The UDI database provides essential details like device identification, manufacturer information, and classification, helping ensure the device meets safety and performance standards required for clinical use in the U.S.