LANCER ORTHODONTICS, INC.

Lancer Orthodontics, Inc. specializes in orthodontic devices, including metal orthodontic brackets like the Intrigue series, which are used in braces to align teeth. They also produce extraoral headgear, such as the Lancer Gear, designed to correct jaw alignment by applying external force. Additionally, the company manufactures fatty acid-based dental cement, such as Rely-a-Bond, which bonds orthodontic appliances to teeth, and optical brackets like the Optyc for enhanced visibility during treatment.

Lancer Orthodontics, Inc. is based in the United States. Since it operates within the U.S., its devices must comply with U.S. regulatory requirements, including those set by the FDA. This includes classification under FDA’s regulatory framework, ensuring safety, effectiveness, and proper labeling for its orthodontic products like brackets, headgear, and dental cement.

Lancer Orthodontics, Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices like orthodontic brackets (e.g., Intrigue), headgear (e.g., Lancer Gear), and dental cements (e.g., Rely-a-Bond) throughout their lifecycle, ensuring transparency and regulatory compliance.

All of Lancer Orthodontics, Inc.’s listed devices fall under FDA Class II regulation. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Examples include orthodontic brackets, headgear, and dental cements, which require validation of performance and labeling requirements to meet regulatory standards.