PRIME DENTAL

Prime Dental specializes in dental restorative materials, focusing on composite resins for fillings, such as flowable and nano-hybrid varieties. Their portfolio also includes dentine bonding agents that cure under visible light, temporary crown/bridge resins, root canal cleaning solutions, chemical-cure core build-up materials, and home-use dental cements designed for temporary restorations. These products are primarily used in restorative and endodontic dental procedures.

Prime Dental is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA classifies Prime Dental’s products as either Class I or Class II devices, depending on their risk level and intended use. Class I devices generally pose minimal risk, while Class II devices require special controls to ensure safety and effectiveness. The company’s devices are also listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor them in the regulatory system.

Prime Dental’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is designed to improve the tracking and identification of medical devices, including dental products, to enhance patient safety and regulatory oversight. Listing in this database ensures transparency and compliance with FDA requirements for device identification and traceability.

Prime Dental’s devices are classified under the FDA’s Class I and Class II categories. The classification determines the regulatory pathway and controls required for each product. Class I devices, such as some dental cements or low-risk materials, typically undergo general controls like good manufacturing practices. Class II devices, such as composite resins or bonding agents, require additional performance standards or post-market surveillance to ensure safety and effectiveness. This classification helps the FDA balance oversight with innovation while ensuring patient safety.