3Shape Implant Studio™ receives FDA 510(k) market clearance
Copenhagen, November 20th, 2014 – 3Shape, a leading global innovator of digital 3D solutions for dental labs and dental clinics, is proud to announce that the U.S. Food and Drug Administration (FDA) has granted (510k) market clearance for the sale of its Implant Studio™ software in the USA.
3Shape Implant Studio™ software merges CT/ Cone Beam CT imaging with 3D digital surface scans of the teeth and gingival situation to provide a digital view of dental patients.
The software then enables dental professionals to evaluate the clinical situation including bone density and nerve positions for creating prosthetic implant planning and surgical guide design.
3Shape Implant Studio™ is used extensively in Asia, Europe and South America.
“3Shape is very excited about this FDA (510k) market clearance which opens the door to new service options for both clinics and labs 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,” says Flemming Thorup, 3Shape’s President and CEO.
Implant Studio™ and digital technology in general, have had a major impact on dental implantology.
In an interview with 3Shape, leading dental practitioner, Dr. Jonathan L. Ferencz summed up the considerable change by saying: “The difference digital dentistry has made to making a crown is tremendous. But the difference it has made in implant dentistry is night and day.*
The dental implant market in the U.S. is projected to reach $5 billion by 2018. With 3 million Americans already having implants. That number is predicted to grow by 500,000 per year, according to the American Academy of Implant Dentistry.
Implant Studio will be available through 3Shape resellers early Q1 2015. Availability to end-users will depend on the specific system configuration.
3Shape experts will be demonstrating Implant Studio including complete workflows using intraoral and CBCT scans, at the 2014 Greater NY Dental Meeting, November 30th to December 3rd, 3Shape booth 424. http://www.gnydm.com/
See Implant Studio™ video: http://youtu.be/N1aogyre1_M