Hespeler Orthodontics Limited

Hespeler Orthodontics Limited specializes in orthodontic devices used in fixed dental treatments. Their product range includes metal orthodontic brackets, archwires made from nickel-titanium and stainless steel, crimpable stops, buccal tubes, and self-ligating bracket tools. They also produce accessories like archwire protection sleeves, orthodontic pliers, power arms, locks, and kits for patient transfers or compression hooks. These devices are primarily designed to align teeth, manage wire tension, and support orthodontic appliances during treatment.

Hespeler Orthodontics Limited is based in the United States. As a manufacturer of orthodontic hardware, their devices are subject to U.S. regulatory standards. Since all their products fall under Class I classification, they must comply with FDA requirements for medical devices, including registration, listing, and adherence to quality system regulations. Their devices are also included in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and transparency in the supply chain.

Hespeler Orthodontics Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures that each product has a standardized identifier for tracking, compliance, and transparency in the medical device supply chain. While the company itself may not be listed in broader manufacturer directories, their individual devices are accounted for in this official U.S. regulatory database.

All of Hespeler Orthodontics Limited’s orthodontic devices are classified as Class I under U.S. regulations. This classification applies to low-risk devices that pose minimal potential harm to patients, such as brackets, archwires, and orthodontic tools. Class I devices typically require general controls (like proper labeling and manufacturing practices) rather than specialized premarket reviews, though they must still meet FDA registration and listing requirements.