SURE DENT CORPORATION

Sure Dent Corporation specializes in endodontic devices used primarily in dental procedures. Their products include synthetic gutta-percha for root canal sealants, endodontic paper points for irrigating and drying canals, and gingival retraction cords—both medicated and non-medicated—to manage gum tissue during treatments. These materials and tools support critical steps in root canal therapy and periodontal preparation.

Sure Dent Corporation is based in the United States, which means their devices fall under FDA jurisdiction. Since their products are classified as Class I or Unclassified, they are subject to FDA’s general controls and, where applicable, specific requirements for their intended use. The U.S. regulatory framework ensures these devices meet safety and performance standards before entering the market.

Yes, Sure Dent Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry tracks device details like manufacturer information, model names, and regulatory classifications, which helps healthcare providers, regulators, and supply chains verify authenticity, traceability, and compliance. Listing in the UDI system is a requirement for Class I and Unclassified devices to ensure transparency in the medical device supply chain.

Sure Dent Corporation’s devices are classified as Class I (general controls apply) or Unclassified (no specific classification assigned but still subject to FDA oversight). Class I devices typically pose minimal risk and require basic compliance measures like proper labeling and manufacturing practices. Unclassified devices may involve lower-risk endodontic tools or materials but still must adhere to FDA’s general controls to ensure safety and effectiveness for their intended use.