3Shape recently received FDA 510(k) market clearance for 3Shape Ortho System 2017 software.
The clearance for the orthodontic software includes the company’s digital indirect bonding placement and transfer media application (IDB), as well as appliance design and production workflows, according to a press release.
3Shape Ortho System makes it possible for orthodontic 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 orthodontic appliances. Users can easily bring a patient’s malocclusion up on screen, and the software will suggest an ideal setup.
The digital setup can be used to plan an indirect bonding bracket treatment as well as to create the transfer media. More than 275 bracket libraries are integrated with the software.
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3Shape Orthodontic software with IDB bracket workflow receives FDA 510(k) market clearance
Copenhagen– 3Shape announces that the U.S. Food and Drug Administration (FDA) grants 510(k) USA market clearance for 3Shape Ortho System™ 2017 software for orthodontics.
This FDA market clearance includes 3Shape’s innovative digital indirect bonding placement and transfer media application (IDB), as well as appliance design and production workflows.
3Shape Ortho System enables orthodontic 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 orthodontic appliances.
Using 3Shape Ortho System, professionals can bring a patient’s malocclusion up onscreen and in just a few clicks, the software suggests an ideal setup.
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.
Over 275 bracket libraries are integrated with the software – see integrated libraries here: https://www.3shape.com/customer-programs/ortho-partner-integrations/bracket-library-integrations