The US Food and Drug Administration (FDA) has granted 510(k) US market clearance for additional indications in the 3Shape Ortho System software for orthodontics. The Ortho System enables orthodontic professionals to overlay digital imaging and communications in medicine, cephalometric, and 2-D 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 the Ortho System’s 510(k) market clearance to include the design of dental retainers, splints, mouthguards, and nightguards in addition to previously cleared indications, including custom metal bands, export models, and indirect direct bonding transfer media. The market clearance also includes 3Shape Indirect Bonding and transfer media solutions, along with several appliance design workflows that guide the user through the design phase and relevant production parameter settings.
According to the company, professionals can use the Ortho System coupled with 3Shape scanners to create digital study models, which save space and costs compared to traditional gypsum models. And because the software enables professionals to work digitally, they can share treatment planning and simulations onscreen with patients as well as seamlessly collaborate between the clinic, lab, and third-party orthodontic solution providers via the 3Shape Communicate cloud platform, the company says.
“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,” said Allan Hydal, vice president of 3Shape Orthodontics.