Tenco

Tenco specializes in orthodontic components, specifically orthodontic metal bands (used to attach brackets to teeth), orthodontic tubes (for securing archwires), and inter-bracket elastic chains (to provide support and alignment between brackets). These devices are designed exclusively for fixed orthodontic treatment to help align teeth and stabilize brackets.

Tenco is based in the United States. The company’s orthodontic devices are intended for use within the U.S. market, where they are regulated under FDA guidelines.

Tenco’s orthodontic devices fall under the FDA’s Class I classification. This classification applies to low-risk devices that pose minimal potential harm to patients, such as orthodontic bands, tubes, and elastic chains. Class I devices typically require general controls (e.g., manufacturing practices, labeling) but do not require pre-market approval.

Yes, Tenco’s devices are included in the FDA’s Unique Device Identifier (UDI) database. Listing in the UDI system ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to identify and track specific devices by their unique identifiers.