3Shape, Copenhagen, Denmark, has received 510(k) market clearance from the US Food and Drug Administration (FDA) for its Ortho System™ 2015 software for orthodontics.
Ortho System allows orthodontists to overlay DICOM, cephalometric, and 2D pictures along with intraoral scans for orthodontic case analysis and planning, treatment submissions, and the design of FDA-cleared orthodontic appliances. Orthodontic professionals can also use the software with the company’s lab scanners to create digital study models.
The digital capabilities of Ortho System allow users to share treatment planning and simulations on-screen with patients as well as collaborate between clinic, lab, and third party orthodontic solution providers via the 3Shape Communicate cloud platform.
According to the company, this FDA market clearance includes 3Shape’s new indirect bonding placement and transfer media solution, as well as several appliance design workflows that guide the user through the design phase and relevant production parameter settings.
