Shenzhen Xpectvision Technology Co., Ltd.

Shenzhen Xpectvision Technology Co., Ltd. specializes in dental imaging and procedural equipment. Its primary products include intraoral digital imaging sensors, reusable dental x-ray film holders, and handheld intraoral digital x-ray systems. These devices are designed for capturing detailed images of teeth and oral structures, as well as for procedural protection in dental settings with single-use medical drapes. The focus is on intraoral applications within dentistry.

The company is based in the United States, which means its devices are subject to U.S. regulatory requirements, including classification under the FDA’s regulatory framework. The U.S. location also influences where its devices are listed, such as in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.

Shenzhen Xpectvision Technology Co., Ltd.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical for tracking and identifying medical devices in the U.S. market, ensuring transparency and compliance with regulatory requirements. The inclusion in this database reflects the company’s adherence to U.S. device identification standards.

The company’s devices are classified as either Class I or Class II under regulatory frameworks. Class I devices generally pose minimal risk and may require less stringent regulatory oversight, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with, as determined by regulatory authorities.