Seilglobal Co., Ltd.

Seilglobal Co., Ltd. specializes in dental devices, including the DentiAnn Smart Sil, which is likely a smart intraoral scanner or digital impression system. These devices are designed to capture detailed oral scans for applications like restorative dentistry or orthodontics, enabling precise digital records of a patient’s teeth and gum structure.

Seilglobal Co., Ltd. is based in the United States, where its devices fall under FDA regulation. Since the company’s products are classified as Class II medical devices, they must comply with the FDA’s 510(k) clearance process—a premarket submission demonstrating substantial equivalence to a legally marketed predicate device—to gain authorisation for market placement.

Seilglobal Co., Ltd.’s devices are listed in the FDA’s 510(k) registry, as they undergo 510(k) clearance for market authorisation in the US. This registry tracks devices that have met FDA requirements for safety and effectiveness through the premarket notification process, ensuring transparency for healthcare providers and regulators.

Seilglobal Co., Ltd.’s devices are classified as Class II under the FDA’s medical device classification system. This classification applies to devices that pose moderate risk and require special controls (beyond general controls) to ensure their safety and performance. For example, digital intraoral scanners like the DentiAnn Smart Sil are typically regulated as Class II due to their role in capturing critical diagnostic data for dental treatments.