Orthodontic technology Innovation in 2025: sma nitinol springs become the core support for 3D printed aligners, ISO New regulations Strengthen medical safety defense

In 2025, the orthodontic field witnessed a dual upgrade in technology and standards. The popularization of direct 3D printed invisible braces has driven the innovation of core materials. Nickel-titanium memory alloy springs, with their advantages of precise force control and biocompatibility, have become the focus of the industry. The new ISO 13485:2025 rule, which was implemented simultaneously, has built a solid quality barrier for medical-grade products.

During the Beijing International Dental Exhibition in June, at the "New Technology Seminar on Direct 3D Printing Invisible Orthodontics", authoritative experts such as Professor Fang Bing from Shanghai Ninth People's Hospital and Professor Zhao Zhihe from West China School of Stomatology unanimously pointed out that biomechanics and materials science are the core foundation for breakthroughs in orthodontic technology. The latest clinical data shows that the 3D printed orthodontic appliances equipped with customized sma nitinol springs have a molars migration efficiency of 93.22% and a press-in efficiency of 54.45%, significantly shortening the treatment cycle compared to traditional orthodontic appliances. The key advantage lies in the superelasticity and shape memory properties of nickel-titanium materials - the nickel-titanium springs prepared through the laser powder bed fusion (LPBF) process The density exceeds 99.5%, and the austenite transition temperature (Af) is precisely controlled at around 39℃, highly matching the human body temperature, enabling precise force application at the 0.15mm level.

Material and process innovations are evolving simultaneously. By 2025, nickel-titanium alloy manufacturing will break through the limitations of traditional processing. By adopting the mechanics-assisted process optimization system, the experimental cycle of spring production was shortened by 70%, and the wire diameter tolerance was controlled within ±0.01mm. Meanwhile, through surface laser remelting technology, the nickel ion exudation was reduced to 0.08μg/cm²/day, which is far below the ISO 10993-15 safety standard. These technological upgrades are in perfect alignment with the new ISO 13485:2025 regulations released in May. This standard, for the first time, incorporates raw material suppliers for 3D printed medical products into the full life cycle management, explicitly requiring them to provide complete biocompatibility test data and digital traceability records.

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Baoji Hanz Metal Material Co., Ltd. is a manufacturer specializing in the research and development of Nitinol Shape Memory Alloy, Superelastic Nitinol Alloy, Nickel Titanium Alloy.

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