Astar Orthodontics Inc.

Astar Orthodontics Inc. specializes in orthodontic devices, including metal orthodontic brackets for fixed braces and extraoral headgear systems. Their brackets feature mini-sized .022-inch slots with specific hook configurations, while their headgear includes reverse pull face masks in multiple colors. These devices are designed to correct dental alignment and apply external forces during orthodontic treatment.

Astar Orthodontics Inc. is based in the United States. As a manufacturer, it adheres to applicable U.S. regulatory requirements for orthodontic appliances, ensuring compliance with FDA guidelines for device safety and performance. However, individual devices must undergo their own regulatory pathways, such as classification and listing, to be authorized for use.

Astar Orthodontics Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their orthodontic brackets and extraoral headgear systems, ensuring transparency in the supply chain and regulatory oversight. Listing in the UDI database is a requirement for Class I devices under FDA regulations.

Astar Orthodontics Inc.’s devices, including orthodontic brackets and extraoral headgear systems, are classified as Class I under FDA regulations. This classification applies to devices that pose minimal risk and typically require only general controls, such as proper labeling and manufacturing practices, to ensure safety and effectiveness. The classification is determined based on the intended use and risk profile of the device.