3Shape wins expanded FDA nod for Ortho System orthodontic software suite

Orthodontic med device firm 3Shape said last Friday it won expanded FDA 510(k) clearance for its 3Shape Ortho System software for orthodontics.

The expanded indications allow for the designing of dental retainers, splints, mouthguards and nightguards in addition to previously cleared custom metal bands, export models and indirect bonding transfer media, the company said.

3Shape’s Ortho System is designed to allow users to overlay DICOM, cephalometric and 2D pictures along with intraoral scans for orthodontic case analysis and planning, as well as treatment simulations and orthodontic appliance design.

“The new FDA clearance for Ortho System now gives US orthodontic practices and lab owners even more options when using the most comprehensive, versatile and easy-to-use orthodontic solution on the market,” VP Allan Hyldal said in a press release.

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