Curve Dental, Inc.

Curve Dental, Inc. specializes in radiology picture archiving and communication system (PACS) workstations. These devices are designed specifically for dental imaging and facilitate the storage, retrieval, and distribution of digital radiographic images within clinical environments. The company’s offerings include standalone and integrated solutions like the Curve Hero™ and Curve Image™ series, all focused on improving workflow efficiency in dental practices.

Curve Dental, Inc. is based in the United States. The company’s PACS workstations are intended for use within the U.S. market, where they support dental professionals in managing digital radiographic images efficiently. The devices are tailored to meet the regulatory and clinical needs of dental practices in the country.

Curve Dental, Inc.’s PACS workstations are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. These registries are used to track and identify medical devices that have undergone the necessary regulatory processes, including premarket notifications and device identification requirements, to ensure compliance with U.S. regulations.

Curve Dental, Inc.’s PACS workstations are classified as Class II medical devices under FDA regulations. This classification is determined based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, and they must comply with specific FDA requirements before being marketed.