Ods Co., Ltd.

Ods Co., Ltd. specializes in dental devices, primarily resin materials for fabrication and CAD/CAM milling systems. Their portfolio includes dental appliance fabrication materials like ODS Clear Resin and Clear Miracle, which are used for retainers and surgical guides, as well as chairside milling systems such as the Scan Cure. These products are designed for in-office dental procedures.

Ods Co., Ltd. is based in the United States. Since the company’s devices are authorised under U.S. regulatory frameworks, they are subject to FDA oversight, including 510(k) premarket notifications and UDI (Unique Device Identification) registrations. This ensures compliance with U.S. medical device regulations.

Ods Co., Ltd.’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process is required for Class I and Class II devices to demonstrate substantial equivalence to legally marketed predicates, while UDI registration ensures traceability and identification of devices in the U.S. market.

Ods Co., Ltd.’s devices fall into Class I and Class II categories under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) submissions.