Jinhua Glamb Medical Equipment Co., Ltd.

Jinhua Glamb Medical Equipment Co., Ltd. specializes in metal orthodontic brackets. These devices are specifically designed for fixed orthodontic treatments to help correct tooth alignment by applying controlled force to reposition teeth. The focus is on dental applications, ensuring compatibility with standard orthodontic systems.

The company is based in the United States. This location allows it to operate within the regulatory framework of the FDA, which governs medical device authorization processes in the country.

Devices from Jinhua Glamb Medical Equipment Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) system. This registry ensures traceability and transparency in the supply chain, helping healthcare providers verify the identity and classification of the devices in use.

The company’s orthodontic brackets fall under Class I medical device classification. This classification is typically assigned to low-risk devices where general controls (such as good manufacturing practices) are sufficient to ensure safety and effectiveness. Class I devices often require less stringent premarket review compared to higher-risk categories.