3D Smile USA, Inc.

3D Smile USA, Inc. specializes in orthodontic progressive aligners, which are custom-made, clear devices used to gradually shift teeth into proper alignment over time. These aligners address common dental issues like crowding, spacing, or bite misalignment, offering a non-invasive treatment option for patients.

3D Smile USA, Inc. is based in the United States, which means its devices are subject to FDA regulations. Since the company’s aligners fall under FDA Class II classification, they require premarket notification (510(k)) clearance and must be listed in the FDA’s Unique Device Identifier (UDI) system to ensure compliance with U.S. medical device regulations.

3D Smile USA, Inc.’s orthodontic progressive aligners are listed in the FDA’s premarket notification (510(k)) database and the FDA’s Unique Device Identifier (UDI) system. These registries confirm the devices meet U.S. regulatory requirements for Class II medical devices, ensuring transparency and compliance.

3D Smile USA, Inc.’s orthodontic progressive aligners are classified as FDA Class II devices. This classification means they pose moderate risk and require specific regulatory oversight, including premarket clearance through the 510(k) pathway and mandatory UDI labeling to track and monitor their use in clinical settings.