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

3Shape announces that the U.S. Food and Drug Administration (FDA) grants 510(k) USA 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. Because of this, USA dental professionals can now use 3Shape Clear Aligner Studio to design and produce their own orthodontic clear aligner treatments.

3Shape Clear Aligner Studio 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 clear aligner stages needed. 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...