Boston Micro Fabrication (BMF), a leader in advanced manufacturing solutions for ultra-high precision applications, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for its innovative UltraThineer™ material used to create the thinnest cosmetic dental veneer in the world. The new 3D printed veneers use projection microstereolithography (PμSL), a technology that enables greater resolution, precision and accuracy, to custom manufacture veneers that are three times thinner than traditional veneers. In addition, UltraThineer requires significantly less preparation for dental professionals, allowing the patient’s original enamel to be preserved with a more realistic final appearance.
“We are excited to hear that UltraThineer veneer has received FDA 510(k) clearance. This is a major milestone for our industry as the ability to 3D print Zirconia veneers is a game changer for dental technology. This breakthrough allows us to offer patients high-quality veneers that require minimal preparation. This is just the beginning of our journey to revolutionize dental care, and we look forward to working with BMF to begin bringing UltraThineer to dental patients across the country.” — Dany Karam, President, Advanced Dental Technologies
UltraThineer veneers are the thinnest veneers in the world and feature advanced material, manufacturing workflow and finishing process to offer more comfortable and less invasive options in cosmetic dentistry. Developed in collaboration with Peking University, dental labs can now offer this ultra-precise alternative to traditional veneers for dental practices across the US, powered by BMF’s unique micro-scale printing technology. Additive manufacturing, or 3D printing, is already proven in multiple dental applications, including orthodontic aligners, mouthguards, drill guides and dentures due to the need for bespoke, personalized and customized solutions.
“After perfecting this process, technology and material for the last year, we are incredibly encouraged by the FDA’s favorable review of the UltraThineer material so that we can quickly offer it to consumers looking for a more improved veneer solution. With the same durability as traditional veneers, dental labs across the US can now offer an improved veneer option that is less invasive to the patient, minimizing tooth loss and improving the overall appearance of teeth.” said Professor Sun Yuchun of Peking University School of Dentistry.
BMF has begun working with dental laboratories in the US and expects to have the products commercially available in the second half of 2024. The UItraThineer material represents the latest innovation offered by BMF as the company strives to explore and create new applications where the Its technology can reduce production time and cost.
“We have continued to innovate our solutions and explore end-use applications that can be uniquely enabled by the PµSL process in dentistry and the life sciences. We are very pleased with our recent 510(k) clearance and the progress we have made toward commercializing this technology to offer more options to patients considering cosmetic dentistry.” said John Kawola, CEO-Global, BMF.
In addition, BMF is developing complementary cosmetic dentistry offerings in international markets to support both direct-to-patient and provider-enabled access to thinner veneers.
