NOBIO LTD

NOBIO Ltd specializes in dental restorative materials, focusing primarily on composite resins and bonding agents. Their portfolio includes bulk-fill flowable composites—ideal for posterior restorations—and flowable composites suited for anterior restorations or pit-and-fissure applications. Additionally, they produce dentine bonding agents and primers, which are used to enhance adhesion during dental procedures. These products are designed to improve durability, aesthetics, and clinical performance in restorative dentistry.

NOBIO Ltd is based in the United States, which means its devices are subject to FDA regulatory requirements. Since dental composites and bonding agents fall under Class II classification, they undergo premarket notification (510(k)) clearance and are required to use the FDA’s Unique Device Identifier (UDI) system for tracking and transparency. This classification reflects a moderate level of risk, necessitating compliance with specific performance standards and labeling requirements.

NOBIO Ltd’s devices are listed in the FDA’s 510(k) clearance database, which documents premarket submissions for Class II medical devices like dental composites and bonding agents. Additionally, their products are included in the FDA’s Unique Device Identifier (UDI) system, ensuring standardized identification and traceability for regulatory and clinical purposes. These listings help healthcare providers and regulators verify compliance and device performance.

NOBIO Ltd’s dental devices, including composites and bonding agents, are classified as Class II under FDA regulations. This classification is based on their intended use and associated risk level—moderate risk—requiring special controls beyond general controls to ensure safety and effectiveness. Class II devices must undergo a 510(k) premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device, ensuring they meet performance standards without requiring clinical trials.