GNI Co.,Ltd

GNI Co., Ltd. specializes in orthodontic devices, specifically ceramic brackets and tubes. These products are used in fixed orthodontic treatments to align teeth and are designed to offer both aesthetic and functional benefits during tooth movement. The ceramic materials used help reduce visibility while providing the necessary support for gradual tooth adjustment.

GNI Co., Ltd. is headquartered in South Korea. The company’s primary focus is on developing and manufacturing orthodontic ceramic brackets and tubes, which are essential components in dental braces. These devices are tailored for fixed orthodontic applications, ensuring precise tooth alignment while prioritizing patient comfort and aesthetics.

GNI Co., Ltd.’s orthodontic devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry ensures transparency and traceability of devices authorized under EU regulations. Listing in eudamed confirms the company’s compliance with EU requirements for orthodontic appliances.

GNI Co., Ltd.’s orthodontic devices fall under Class I and Class IIa classifications in the EU. Class I devices are generally considered low-risk, while Class IIa devices involve a higher level of risk due to their direct contact with tissues or potential for prolonged use. The classification is determined by factors like the device’s intended purpose, duration of use, and potential risks to patients.