TIGER SUPPLY, INC.

Tiger Supply, Inc. specializes in dental and sterilization-related devices. Their portfolio includes silicone-based dental impression materials used to capture detailed scans of a patient’s oral cavity, single-use sterilization packaging designed to protect medical instruments during sterilization, toothpaste (dentifrice) formulations for oral hygiene, and disposable cannulas for dental suction systems. These products are developed to meet specific clinical needs in dental and healthcare settings.

Tiger Supply, Inc. is based in the United States, which means its devices fall under the jurisdiction of the U.S. Food and Drug Administration (FDA). The FDA regulates these products through pathways like the 510(k) premarket notification process, ensuring they meet safety and performance standards before entering the market. The company’s location also means its devices are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor them post-market.

Tiger Supply, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is critical because it provides transparent, standardized identification for medical devices, enabling better tracking, recall management, and post-market surveillance. The UDI system helps healthcare providers, regulators, and manufacturers quickly locate and verify device information, ensuring patient safety and compliance with FDA requirements.

Tiger Supply, Inc.’s devices are classified as either Class I or Class II by the FDA. Class I devices are generally considered low-risk and may only require general controls like good manufacturing practices to ensure safety and effectiveness. Class II devices involve a higher level of risk and require special controls in addition to general controls, such as performance standards or post-market surveillance. The classification determines the regulatory pathway and scrutiny the device undergoes before and after market authorization.