3Shape Indirect Bonding workflow receives FDA 510(k) market clearance
The U.S. Food and Drug Administration (FDA) has granted 510(k) USA market clearance for 3Shape Ortho System™ 2017 software for orthodontics. This clearance includes 3Shape’s innovative digital indirect bonding placement and transfer media application (IDB), as well as appliance design and production workflows.
With 3Shape’s new Indirect Bonding Module, bracket placement workflow starts with a 3Shape TRIOS intraoral scan. The patient’s malocclusion is shown onscreen, and the software suggests an ideal setup. It shows the malocclusion with brackets on one side of a split screen and the teeth in their final position on the other. Setup can be adjusted on either side of the screen, and the corresponding changes are made on the other. Once the ideal setup is approved, the software creates an optional full prescription table; setup preferences can be saved for future cases. Over 275 original manufacturer bracket libraries are integrated in the software, and appliances such as trays can be printed directly from it.
3Shape Ortho System enables ortho-dontic professionals to overlay DICOM, cephalometric, and 2D pictures, along with intraoral scans for orthodontic case analysis and planning, treatment simulations, and the design and production of FDA-cleared ortho-dontic appliances.
The digital setup can be used in the planning of an indirect bonding bracket treatment as well as in creating the transfer media. 3Shape Ortho System intuitively guides the user through the design phase and the relevant production parameter settings.
Like all 3Shape solutions, 3Shape Ortho System is open, so it puts the professional in control. Professionals decide how much of the workflow they want to do in-house and/or send to partners.
Because the workflow is digital, treatment planning and simulations can be shared onscreen with patients as well as seamlessly between practice, lab, and third-party ortho-dontic solution providers via the 3Shape Communicate cloud platform.
Allan Hyldal, Vice President of 3Shape Orthodontics, described the benefits of the system. “The documented accuracy and ease of use of our TRIOS intraoral scanners provides a perfect start to the digital workflow for orthodontists. Doctors and labs using the scans and Ortho System can plan bracket treatments as well as create and produce the transfer media and appliances in-house or at production partners. Coupled with our unrivalled ecosystem of treatment options, 3Shape is opening the doors to growth for practices, labs, and partners.”
Learn more at 3shape.com/indirect-bonding.
3Shape is changing dentistry together with dental professionals across the world by developing innovations that provide superior dental care. The company’s portfolio of 3D scanners and CAD/CAM software solutions for the dental industry includes the multiple award-winning 3Shape TRIOS intraoral scanner, the upcoming 3Shape X1 CBCT scanner, and market-leading scanning and design software solutions for dental labs. Today, 3Shape has over 1,200 employees in over 100 countries from an ever-growing number of 3Shape offices worldwide. 3Shape’s products and innovations continue to challenge traditional methods, enabling dental professionals to treat more patients more effectively.
This information was provided by 3Shape.