3Shape Ortho System Clear Aligner Workflow Receives FDA 510(k) Market Clearance

3Shape Ortho System Clear Aligner Workflow Receives FDA 510(k) Market Clearance
U.S. dental professionals can now use 3Shape Clear Aligner Studio software to produce clear aligners in-house
Posted: October 30, 2018
Edited by Dentaltown staff

COPENHAGEN, Denmark—3Shape recently announced that the U.S. Food and Drug Administration has granted 510(k) market clearance for the 3Shape Ortho System clear aligner workflow.

The 3Shape Ortho System clear aligner workflow is used in 3Shape’s Clear Aligner Studio software. U.S. dental professionals can now use 3Shape Clear Aligner Studio to design and produce their own orthodontic clear aligner treatments. The software guides professionals through the case analysis, setup and staging, and export to print for production.

Using simple and intuitive workflows, the software provides analysis of arch shapes, overjet/overbite, Bolton ratios, occlusion and spaces. From there, virtual setups can be created and subdivided into the necessary clear aligner stages . Attachments and interproximal reduction can also be added to the treatment plan, and when planning is complete, sub-setups can be prepared for printing. Production files can be exported for 3D printing and vacuum forming. The software is also compatible with a wide range of 3D printers.

“Around the world, hundreds of thousands of clear aligners are produced every year using 3Shape Clear Aligner Studio. It is very exciting that USA professionals now have the same opportunity to take total control of their design, budgeting and production of clear aligners,” said Allan Hyldal, vice president of 3Shape Orthodontics.

The 3Shape Clear Aligner Studio is open and professionals are free to decide how much of the workflow they want to do in-house or send to design and production partners.

For more information, visit 3shape.com.

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