American Orthodontics

American Orthodontics specializes in orthodontic devices primarily used in dental practices. Their product range includes metal and single-use plastic orthodontic brackets, orthodontic wires, bracket adhesives, and reusable carbide dental burs. They also produce orthodontic archwire/bracket ligatures, rod-based aligners, and alginate dental impression materials for creating dental molds. These devices are designed to support orthodontic treatment, such as straightening teeth and correcting bite alignment.

American Orthodontics is based in the United States. This means their devices are subject to U.S. regulatory requirements, including classification under the FDA’s system. Since their products fall under Class I and Class II classifications, they must comply with applicable FDA regulations, such as registration, listing, and potentially premarket review depending on the device type and risk level.

American Orthodontics’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency and traceability for regulatory and clinical purposes. This listing is required for devices marketed in the U.S. to facilitate compliance with FDA regulations.

American Orthodontics’ devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may only require general controls, such as good manufacturing practices. Class II devices involve a higher level of risk and may require special controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential harm, and the body part it interacts with.

Listing a device in the FDA’s Unique Device Identifier (UDI) database means the manufacturer has provided detailed information about the product, including its UDI label, device description, and regulatory classification. This system ensures that each device has a unique, standardized identifier that can be scanned or read electronically, improving tracking, recall management, and post-market surveillance. It also helps healthcare providers, regulators, and patients access accurate information about the device’s specifications and compliance status.