Lithoz Certified ISO 13485 for Medical Device 3D Printing

by Medical

Lithoz, a ceramic 3D printing company headquartered in Vienna, has secured ISO 13485 certification for its quality management system, aligning its operations with international standards for medical device manufacturing. The certification, regarded as the benchmark for regulatory compliance in healthcare production, enables Lithoz to meet FDA Quality System Regulation (QSR) requirements and expands its role in supplying 3D printed components for medical and dental applications.

Skillbond Becomes TRUMPF Dental 3D Printer Reseller in UK

by Medical

Skillbond Direct Ltd, a UK-based provider of digital manufacturing solutions for dental laboratories, has purchased two TruPrint 1000 systems from TRUMPF and entered into a reseller agreement limited to the UK dental sector. The move supports the company’s plans to expand its offering to include cobalt-chrome removable partial dentures (RPDs), a lightweight and durable alternative to acrylic dental prosthetics.

“Game-changing Milestone” as Lithoz Beta-TCP Implants Show 92% Success in Long-Term Clinical Evaluation

by Medical

Austrian ceramic 3D printing company Lithoz has achieved a 92% success rate in a clinical long-term follow-up study of its beta TCP patient-specific implants (PSI). The study confirmed that its 3D printed implants made using Lithoz’s CeraFab printer are effective bone substitutes, showing strong osteoconductive and osteoinductive properties with no post-surgical complications. The study’s findings aim to support the broader clinical adoption of ceramic 3D printing in surgical applications.

Stratasys expands dental 3D printing network in Europe with three new partners

by Medical

Stratasys Ltd. (NASDAQ: SSYS), a global provider of polymer 3D printers, has announced new strategic partnerships with three European dental distributors: Nueva Galimplant (Spain), Gold Quadrat (Germany), and Metaux Precieux (Germany). These collaborations will expand the reach of Stratasys’ dental 3D printing portfolio, including TrueDent™, a full-color, monolithic digital denture solution. Stratasys’ dental offering includes mixed-application printing, such as crowns, bridges, and orthodontic models, on a single tray, streamlining workflows and enabling mass customization. These features are especially attractive to labs seeking to increase throughput without scaling labor. During IDS 2025, the leading European dental trade fair, Stratasys exhibited its multi-material 3D printing capabilities across dental applications, from orthodontics to crowns and bridges.

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FDA Grants IND Approval to Triastek’s 3D Printed Oral Anticoagulant T20G

by Medical

Triastek, a Chinese 3D printing pharmaceutical company, has announced that its proprietary 3D printed non-vitamin K antagonist oral anticoagulant (NOAC), T20G, has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA) as of February 27, 2025. This regulatory achievement follows an earlier IND approval from China’s National Medical Products Administration (NMPA) in January 2024.