3Shape Ortho System receives FDA 510(k) market clearance
FDA clearance now also covers design of dental retainers, splints, nightguards and mouthguards
Copenhagen– 3Shape announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) USA market clearance for additional indications in 3Shape Ortho System™ software for orthodontics.
3Shape Ortho System enables orthodontic professionals to overlay DICOM, cephalometric, and 2D pictures along with intraoral scans for orthodontic case analysis and planning, treatment simulations and the design of FDA-cleared orthodontic appliances.
The FDA now extends Ortho System’s 510(k) market clearance to include the design of dental retainers, splints, mouthguards and nightguards in addition to previously cleared indications: custom metal bands, export models, and indirect direct bonding transfer media.
3Shape will present the solution at its press conference at the American Association of Orthodontists meeting in San Diego (AAO 2017), April 22, 10:00AM – booth #3519.
Professionals use 3Shape Ortho System coupled with 3Shape scanners to create digital study models. Digital study models provide a space and cost saving alternative to traditional analog gypsum models.
Because the software enables professionals to work digitally, they are able to share treatment planning and simulations onscreen with patients as well as seamlessly collaborate between clinic, lab, and 3rd party orthodontic solution providers via the 3Shape Communicate cloud platform.
This FDA market clearance also includes 3Shape Indirect Bonding and transfer media solutions, as well as several appliance design workflows that guide the user through the design phase and relevant production parameter settings.
“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,” says Allan Hyldal, Vice President of 3Shape Orthodontics.