Lithoz Certified ISO 13485 for Medical Device 3D Printing

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

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

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.