3Shape_clearalignerstudio3Shape, Copenhagen, announced that the U.S. Food and Drug Administration (FDA) has granted 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. The clearance allows dental professionals in the United States to now use 3Shape Clear Aligner Studio to design and produce their own orthodontic clear aligner treatments.

3Shape Clear Aligner Studio guides users through case analysis, setup and staging, and export to print for production. The software provides analysis of arch shapes, overjet/overbite, Bolton ratios, occlusion and spaces. Following this analysis, 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 exported for 3D printing and vacuum forming.

The software is compatible with a range of 3D printers, according to 3Shape.

3Shape Clear Aligner Studio is an open platform, giving users the ability to decide how much of the workflow they want to do in-house and/or send to design and production partners. In addition, the digital workflow, treatment planning, and simulations can be shared onscreen with patients as well as between the practice and lab via the 3Shape Communicate cloud platform.