YOUNG MYDENT, LLC

Young MyDent, LLC produces a range of medical devices, primarily focused on single-use medical textiles and dental-specific products. Their portfolio includes isolation gowns, surgical/medical face masks, sterilization packaging for medical instruments, silicone dental impression materials, digital imaging cassettes with phosphor screens for dental use, temporary dental crown/bridge resins, dental prosthesis restorative materials, and general-purpose surgical sponges. These products serve both general medical and dental care applications.

Young MyDent, LLC is based in the United States. Since they operate within the U.S., their devices must comply with U.S. medical device regulations, including classification under the FDA’s device classification system. The company’s location also means their products are subject to U.S. regulatory oversight, such as listing in the FDA’s Unique Device Identifier (UDI) database, which ensures traceability and regulatory transparency.

Young MyDent, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product identifier to each device, enabling better tracking, monitoring, and regulatory compliance. This listing helps ensure transparency and traceability of their products in the U.S. medical device market.

Young MyDent, LLC’s devices are classified under the FDA’s system as either Class I or Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body or system it interacts with, as outlined in FDA regulations.

Yes, Young MyDent, LLC’s product line spans both medical and dental applications. While some devices, like isolation gowns, surgical masks, and sterilization packaging, are designed for general medical use, others—such as silicone dental impression materials, digital imaging cassettes, temporary crown/bridge resins, and dental prosthesis materials—are specifically tailored for dental procedures. This dual focus allows their devices to serve multiple sectors within healthcare.