The medical space is set to be the first major industry to be galvanized by 3D printing technology, uniting many of 3D printing’s strengths in a field that has immediate, life-enhancing effects. While operating rooms the world over are now implementing the technology to perform vital surgeries, taking advantage of patient-tailored implants and patient-specific surgical models, the FDA is now catching on to 3D printing’s increasingly important role in medicine. The Food and Drug Administration has now approved 3D printed facial, cranial, and multiple spinal implants, as well as the first 3D printed pharmaceutical, and, today, it has given clearance to a material for 3D printing parts of dentures.
Orthodontic company DENTCA has received 510(k) approval of a material that will be used to 3D print the bases of dentures, allowing DENTCA to create perfectly tailored dentures and baseplates from patient scans. Printed via stereolithography (SLA), the resin dentures can be made directly from 3D models, instead of through casts, allowing the company to automate the manufacturing process.
Dr. Jason Lee, inventor of the process, explains, “After several years in development DENTCA’s new 3D printable Denture Base is finally cleared for use. We are very excited to begin applying this technology to continue revolutionizing the denture world. The material is a light-cured resin indicated for fabrication and repair of full and partial removable dentures and baseplates; which will eventually replace traditional heat-cured and auto polymerizing conventional denture making methods.” He continues, “By improving the manufacture process with the help of precise 3D printers, we will be making the denture production process quicker, more accurate and more predictable. DENTCA already revolutionized the fit of dentures by directly scanning the impressions instead of the need to pour a stone; now it will further increase it by removing the need for a flask in the future market, thus significantly reducing distortion.”
DENTCA’s Denture Base involves a unique system that combines the company’s denture file database with an optical impression system, the SLA printer, and the necessary light curing to create a complete, closed cycle for producing their dentures. Now that the material involved has received FDA approval, deemed suitable for contact with human tissue for longer than 30 days, the product can be brought to market. DENTCA envisions their systems installed in doctor’s offices, with CEO Sun Kwon saying, “This clearance completely revolutionizes the denture manufacture process, which has barely changed in over 100 years. The new developments will create incredible possibilities for patients, as doctors will soon be able to 3D print final dentures at their office, allowing the manufacture process to be done in one day everywhere in the world. Stay tuned for new and exciting updates.”
It’s exciting to see an increasing range of technologies and materials approved by the FDA so that 3D printing can more quickly improve the lives of those with access to it.
