FDA Clears BMF’s Cosmetic Veneer Material

Boston Micro Fabrication (BMF) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its UltraThineer material, used to create the world’s thinnest cosmetic dental veneer. The new 3D printed veneers use projection micro stereolithography (PµSL), a technology that allows for greater resolution, accuracy and precision, to custom-manufacture veneers that are three-times thinner than traditional veneers, according to the company. UltraThineer also requires significantly less preparation for dental professionals, allowing preservation of the patient’s original enamel with a more realistic final appearance.
 
“We are thrilled to hear the UltraThineer veneer has received FDA 510(k) clearance. 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 revolutionize dental care, and we look forward to working with BMF to begin offering the UltraThineer to dental patients across the country” said Dany Karam, president of Advanced Dental Technologies at BMF.
 
UltraThineer veneers feature advanced material, a production workflow, and a finishing process to deliver more comfortable and less invasive options in cosmetic dentistry. Developed in collaboration with Peking University, dental labs can now offer this alternative to traditional veneers for U.S. dental practices. the Additive manufacturing, or 3D printing, is already proven across multiple dental applications including orthodontic aligners, mouthguards, drill guides, and dentures due to need for on-demand, personalized, and custom solutions.
 
“After refining this process, technology and material for the last year, we’re 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. 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, minimizing tooth reduction and improving the overall appearance of teeth,” said Professor Sun Yuchun, with Peking University’s School of Stomatology.
 
BMF has begun to partner with U.S. dental labs and expects to have the products commercially available in the second half of 2024. 
 
“We’ve continued to innovate our solutions and explore end-use applications that can be 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’ve made towards commercializing this technology to offer more options for patients considering cosmetic dentistry,” BMF Global CEO John Kawola commented.
 
BMF is developing complementary cosmetic dentistry offerings in international markets to support both direct-to-patient and provider-enabled access to thinner veneers.

Boston Micro Fabrication provides highly precise, micro-scale 3D printing services for the healthcare, life sciences, electronics, and machining industries. Using the company’s proprietary PμSL (Projection Micro Stereolithography) technology, the microArch system printers produce the industry’s most accurate and precise high-resolution 3D prints for product development, research, and industrial short run production. Founded in 2016, BMF has offices in Boston, Shenzhen (China), Chongqing (China), and Tokyo with a research and development center in San Diego.