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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.
波士顿微制造公司(BMF)因其超薄材料获得美国食品和药物管理局(FDA)510(k)的许可,该材料用于制造世界上最薄的美容牙科贴面。据该公司介绍,新的3D打印贴面使用投影显微立体光刻(PµSL)技术定制比传统贴面薄三倍的贴面,该技术具有更高的分辨率、准确性和精度。
UltraThineer also requires significantly less preparation for dental professionals, allowing preservation of the patient’s original enamel with a more realistic final appearance..
UltraThineer还需要为牙科专业人员做更少的准备,从而可以保存患者的原始牙釉质,并具有更真实的最终外观。。
“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.
“听到UltraThineer贴面获得FDA 510(k)许可,我们感到非常兴奋。这对我们的行业来说是一个重要的里程碑,因为能够在氧化锆中3D打印贴面是牙科技术的游戏规则改变者。这一突破使我们能够为患者提供需要最少准备的高质量贴面。
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..
这只是我们彻底改变牙科护理之旅的开始,我们期待着与BMF合作,开始为全国的牙科患者提供超薄剂。”BMF高级牙科技术总裁Dany Karam说道。。
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.
UltraThineer贴面采用先进的材料、生产流程和精加工工艺,为牙科美容提供更舒适、更少侵入的选择。牙科实验室与北京大学合作开发,现在可以为美国牙科实践提供传统贴面的替代品。
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..
由于需要按需、个性化和定制的解决方案,增材制造或3D打印已经在多种牙科应用中得到验证,包括正畸对准器、护齿器、钻孔导板和假牙。。
“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.
“在去年改进了这一工艺、技术和材料后,FDA对超薄材料进行了权宜之计的审查,我们对此感到鼓舞,因此我们可以迅速将其带给消费者,寻找更简化的贴面解决方案。美国各地的牙科实验室拥有与传统贴面相同的耐用性。
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..
北京大学口腔医学院的孙宇春教授说:“现在可以提供一种改进的贴面选择,对患者没有那么大的侵入性,最大程度地减少牙齿的减少,改善牙齿的整体外观。”。。
BMF has begun to partner with U.S. dental labs and expects to have the products commercially available in the second half of 2024.
BMF已开始与美国牙科实验室合作,预计该产品将于2024年下半年上市。
“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全球首席执行官约翰·卡沃拉(JohnKawola)评论道:“我们一直在不断创新解决方案,探索牙科和生命科学中PµSL流程可以实现的最终应用。我们对最近的510(k)许可以及我们在商业化这项技术方面取得的进展感到非常高兴,为考虑美容牙科的患者提供了更多选择。”。。
BMF is developing complementary cosmetic dentistry offerings in international markets to support both direct-to-patient and provider-enabled access to thinner veneers.
BMF正在国际市场上开发互补的牙科美容产品,以支持直接面向患者和提供者获得更薄的贴面。
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.
波士顿微制造为医疗保健、生命科学、电子和机械加工行业提供高精度、微型3D打印服务。Microach系统打印机使用公司专有的PμSL(投影显微立体光刻)技术,为产品开发、研究和工业短期生产生产生产业界最准确和精确的高分辨率3D打印。
Founded in 2016, BMF has offices in Boston, Shenzhen (China), Chongqing (China), and Tokyo with a research and development center in San Diego. .
BMF成立于2016年,在波士顿、深圳(中国)、重庆(中国)和东京设有办事处,在圣地亚哥设有研发中心。。