Newsletter
ROCKVILLE, Md., USA/COPENHAGEN, Denmark: Digital dental solutions provider 3Shape has announced that it has been granted market clearance for the sale of its Implant Studio software in the U.S. by the Food and Drug Administration (FDA). The software, which allows dental professionals to evaluate bone density and nerve position in patients for prosthetic implant planning and surgical guide design, will be available in the U.S. in early 2015.
"3Shape is very excited about this FDA—510(k)— market clearance which opens the door to new service options for both clinics and laboratories in North America. Importantly, as more and more people are choosing dental implants to meet their restoration needs, Implant Studio will enable dental professionals to more effectively care for them," stated Flemming Thorup, the company's president and CEO.
The U.S. dental implant market is projected to reach $5 billion by 2018. This development can be attributed to technological innovations and a growing aging population worldwide. Digital technologies in general have become increasingly important in dental implantology and more people are having dental implants placed. According to the American Academy of Implant Dentistry, 3 million Americans have implants and that number is growing by 500,000 per year.
3Shape stated that Implant Studio will be available through its resellers from the first quarter of 2015. However, availability to end users will depend on the specific system configuration. The software is already available in Asia, Europe and South America.
In addition, the company announced that its digital experts will be demonstrating Implant Studio, including complete workflows using intra-oral and CBCT scans, at the 2014 Greater New York Dental Meeting (Booth 424), which will take place from Nov. 30 to Dec. 3.
