Ultra-Thin Cosmetic Veneers Approved by FDA

BMF Receives Clearance for Revolutionary Veneer Material

USA: Boston Micro Fabrication (BMF), a pioneer in advanced manufacturing solutions, has achieved a significant milestone by securing U.S. Food and Drug Administration (FDA) 510(k) clearance for its UltraThineer material used to create the world’s thinnest cosmetic dental veneers.

New Technology for Minimally Invasive Veneers

The newly approved 3D printed veneers, manufactured using projection micro stereolithography (PµSL), offer unparalleled precision and resolution. These ultra-thin veneers are three times thinner than traditional options, requiring significantly less preparation from dental professionals and preserving more of the patient’s natural enamel. The result is a remarkably realistic and comfortable final appearance.

“We are thrilled to hear that 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,” said Dany Karam, President of Advanced Dental Technologies.

Boston Micro Fabrication Unveils UltraThineer Veneers

Collaboration with Peking University Yields Revolutionary Results

Developed in collaboration with Peking University, dental labs across the United States can now offer this revolutionary alternative to traditional veneers, powered by BMF’s cutting-edge micro-scale 3D printing technology.

“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,” said Professor Sun Yuchun of Peking University School of Stomatology.

Expanding Access to Innovative Dental Solutions

BMF has already begun partnering with dental labs in the U.S. and expects to have the UltraThineer products commercially available in the second half of 2024. This innovation represents BMF’s commitment to exploring new applications where its technology can reduce production time and cost.

“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. 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,” added John Kawola, CEO-Global of BMF.

Furthermore, BMF is developing complementary cosmetic dentistry offerings in international markets to support both direct-to-patient and provider-enabled access to these thinner veneers.