SoftSmile Gets FDA’s 510(k) Clearance for Its Vision Aligner Software

New York City-based orthodontic software company SoftSmile’s Vision aligner software has received the FDA’s 510(k) clearance.

The software enables doctors to create precise orthodontic aligners that are then manufactured using 3D printing technologies.

SoftSmile is currently working with several aligner manufacturers, but will now start marketing Vision as a standalone application to be used directly by doctors, the company said.