3Shape has received new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Ortho System clear-aligner workflow.
The Ortho System workflow is part of the company's Clear Aligner Studio software, so U.S. dentists can now use the software to design and produce orthodontic clear aligners. The FDA previously cleared the most recent version of the software in early 2018 as well as some design features in 2017.
