Eclear International Co., Ltd.

Eclear International Co., Ltd. specializes in orthodontic progressive aligners, which are custom-fitted dental trays designed to gradually shift teeth into alignment. These devices are primarily used in orthodontic treatments to correct minor to moderate dental irregularities over time.

The company is headquartered in the United States. This location influences its regulatory compliance, particularly under U.S. FDA guidelines for medical devices.

Eclear International’s orthodontic progressive aligners fall under Class I and Class II classifications under FDA regulations. Class I devices are generally low-risk, while Class II devices require additional controls due to moderate risk, such as ensuring proper design and manufacturing processes. This classification determines the regulatory pathway, such as 510(k) clearance for Class II devices.

Eclear International’s devices are listed in the FDA’s 510(k) clearance database (for Class II devices) and the FDA’s Unique Device Identifier (UDI) system. These registries ensure transparency in device identification, compliance, and traceability for healthcare providers and regulators.