Boston Micro Fabrication
Boston Micro Fabrication (BMF) has received FDA 510(k) clearance for its UltraThineer material, which enables what BMF believes to be the world’s thinnest cosmetic dental veneers.
The UltraThineer solution was launched by BMF last year.
With BMF’s Projection Micro Stereolithography (PµSL) technology, dental veneers can be manufactured to be three times thinner than traditional veneers. They can also be custom-made and are said to boast greater resolution, accuracy and precision compared to traditionally-made products.
BMF has sought to develop a material that can advance the development and manufacture of veneers to deliver a product that is more comfortable and less invasive. According to the company, UltraThineer requires significantly less preparation for dental professionals, allowing preservation of the patient’s original enamel with a more realistic final appearance.
“We’ve 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,” said John Kawola, CEO-Global, BMF. “We are very pleased with our recent 510(k) clearance and the progress we’ve made towards commercialising this technology to offer more options for patients considering cosmetic dentistry.”
The UltraThineer material has been developed in collaboration with Peking University, with BMF now beginning to partner with dental labs in the US. It is expected products will be commercially available in the second half of 2024.
“After refining this process, technology and material for the last year, we’re incredibly encouraged by the FDA’s expedient review of the UltraThineer material so we can quickly bring it to consumers looking for a more streamlined veneer solution,” offered Professor Sun Yuchun, Peking University School of Stomatology. “With the same durability as traditional veneers, dental labs across the U.S. can now deliver an improved veneer option that isn’t as invasive for the patient, minimising tooth reduction and improving the overall appearance of teeth.”
"We are thrilled to hear that the UltraThineer veneer has received FDA 510(k) clearance,” added Dany Karam, President, Advanced Dental Technologies. “This is a significant milestone for our industry as having the ability to 3D print veneers in Zirconia is a game changer for dental technology. This breakthrough allows us to offer patients high quality veneers that require minimum prepping. This is just the beginning of our journey to revolutionise dental care, and we look forward to working with BMF to begin offering the UltraThineer to dental patients across the country.”
