Blue Dent Dental

Blue Dent Dental specializes in EVOLUX CAD/CAM PMMA BLOCKS, which are pre-polymerized polymethyl methacrylate (PMMA) materials. These blocks are designed for use in computer-aided design and manufacturing (CAD/CAM) systems to create dental prosthetics, such as crowns, bridges, or inlays.

Blue Dent Dental is based in the United States. While the company’s headquarters and manufacturing operations are located there, the regulatory information provided does not specify international operations or distribution beyond the U.S. context.

Blue Dent Dental’s devices are regulated under the FDA’s 510(k) clearance pathway in the United States. This pathway is used for Class II medical devices, which are considered to have an acceptable level of risk and do not require the same rigorous premarket approval process as higher-risk devices.

Blue Dent Dental’s devices fall under FDA Class II classification. This classification is assigned based on the risk associated with the device—Class II devices are generally considered to have a moderate level of risk and require specific controls, such as performance standards or post-market surveillance, to ensure safety and effectiveness.