Home » BMF Receives FDA 510(k) Clearance for Cosmetic Dental Veneers

BMF Receives FDA 510(k) Clearance for Cosmetic Dental Veneers

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BMF Receives FDA 510(k) Clearance for Cosmetic Dental Veneers

Thanks to BMF, individual dental veneers can be made three times thinner than before. (Image source: Boston Precision Inc.)

Boston, Munich, April 23, 2023. Boston Micro Fabrication (BMF), a leading provider of advanced manufacturing solutions for ultra-precision applications, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative UltraThineer™ material receive. This produces the thinnest cosmetic dental veneers in the world. Precision Micro Stereolithography (PµSL), a 3D printing technology from BMF, enables high resolution, accuracy and precision. This means that the individual dental veneers can be made three times thinner than before. Additionally, UltraThineer requires significantly less preparation by dentists, preserving more of the patient’s enamel and making the appearance more realistic.

“We are thrilled with the news that the UltraThineer veneer has received FDA 510(k) clearance. The ability to 3D print zirconium dioxide dental veneers is a breakthrough in dental technology and a significant milestone for our industry. This allows us to offer patients high-quality veneers that require only a minimum of pretreatment. This is just the beginning of a revolution in dental care. We look forward to working with BMF to bring UltraThineers to dental patients across the country,” said Dany Karam, President of Advanced Dental Technologies.

UltraThineers are the thinnest dental veneers in the world and feature advanced materials and production processes, providing more comfortable and less invasive cosmetic dentistry treatments. Thanks to a collaboration with Peking University, dental laboratories can now offer this high-precision alternative to traditional veneers to dental practices across the United States. They use BMF’s unique micro-printing technology. Additive manufacturing has already proven itself in numerous dental applications, such as orthodontic aligners, mouth guards, drilling templates and dentures, which are to be manufactured individually if required.

“After refining the process, technology and material over the past year, we are incredibly encouraged by the FDA’s expedited review of UltraThineer material. Dental laboratories in the U.S. can now offer patients an option that is less invasive, limits tooth reduction, and improves the overall appearance of teeth while maintaining the same durability as traditional dental veneers,” says Professor Sun Yuchun, of Peking University School of Stomatology.

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BMF is now partnering with dental laboratories in the US and expects the products to be available on the market in the second half of 2024. The UltraThineer material is BMF’s latest innovation. The company wants to research and establish new applications where PµSL technology can reduce production time and costs.

“We have continuously developed our solutions and discovered applications in dentistry and life sciences that are only possible with the PµSL process. We are very pleased with our 510(k) clearance and our progress in commercializing this technology. This allows us to offer more options to patients considering cosmetic dental treatment,” explains John Kawola, CEO-Global at BMF.

In addition, BMF is developing complementary offerings in cosmetic dentistry for the international market to provide both patients and providers with access to thinner dental veneers. For more information about Venust, the cosmetic dentistry solution available in China, visit www.venust.cn

For more information please visit www.ultrathineer.com

Image source: Boston Precision Inc.

Über BMF – Boston Micro Fabrication

Boston Micro Fabrication (BMF) enables high-precision 3D printing of micro-scale components used in healthcare, life sciences, electronics and mechanical engineering. Using the company’s proprietary PμSL (projection micro-stereolithography) technology, the printers in the microArch system produce very accurate and precise high-resolution 3D prints for product development, research and industrial small series. Founded in 2016, BMF has offices in Boston, Shenzhen, Chongqing and Tokyo, as well as a research and development center in San Diego. For more information about BMF, please visit www.bmf3d.com or follow the company on LinkedIn at

Company contact
BMF Precision Inc.
Laura Galloway
8 Mill and Main Suite 310
MA 01754 Maynard
(001)(978) 637-2050

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Press contact
hightech marketing e.k.
Dr. Thomas Tosse
Inner Wiener Straße 5
81667 München
089/4591158-0
+49 89 459 11 58 11

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