3Shape Ortho System receives FDA 510(k) market clearance
FDA clearance now also covers design of dental retainers, splints, nightguards and mouthguards
Copenhagen, April 21, 2017 – 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.
Copenhagen, April 17, 2017 – 3Shape Indirect Bonding application, an application within 3Shape Orthodontics, announces digital integration with RMO Bracket Systems.
The integration enables orthodontists and labs using the FDA-cleared 3Shape indirect bonding solution to first, virtually plan patient treatment using the RMO Bracket Systems libraries and then, place the physical RMO brackets using digitally-designed and 3D printed transfer trays.
The virtual RMO Bracket Systems libraries can be accessed directly from within 3Shape orthodontic software as of April 18, 2017.
Treatment planning and bracket placement of the virtual libraries are made using a digital study model of the patient. The models are created with a TRIOS intraoral scan or conventional impression scanned with a 3Shape dental lab scanner. After treatment planning, the physical bracket systems are bonded in the patient using transfer trays also designed with the 3Shape indirect bonding software and printed with a 3D printer.
The RMO Bracket Systems join more than 200 original bracket libraries and orthodontic solution providers now integrated with the 3Shape orthodontic software.
“We are very excited to add RMO Bracket Systems to the growing list of bracket libraries and orthodontic solution providers now integrated with our 3Shape orthodontic solutions. Professionals using RMO Systems can now take advantage of our optimized indirect bonding workflow to reduce chair time and increase treatment efficiency and patient comfort,” says Allan Junge Hyldal, Vice President 3Shape Orthodontics.
“Through the years RMO has pioneered the industry with a strong value on innovation and collaboration,” says Tony Zakhem, CEO, Rocky Mountain Orthodontics. “We look forward to partnering with 3Shape to give orthodontists a U.S. manufactured bracket option that is synergistic at its core.”
3Shape Orthodontics gets exclusive integration with American Orthodontics Bracket Systems
Copenhagen, April 18, 2017– 3Shape announces its Indirect Bonding application becomes the first orthodontic software solution to integrate digitally with proprietary American Orthodontics Bracket Systems libraries.
The exclusive integration enables orthodontists and labs using the FDA-cleared 3Shape indirect bonding solution to first, plan patient treatment using the virtual American Orthodontics Bracket System library and then, bond the physical AO brackets using digitally-designed transfer trays.
Select American Orthodontics Bracket System libraries can be accessed directly in 3Shape orthodontic software. Treatment planning and bracket placement of the virtual libraries are made using a digital study model of the patient and/or with the 3Shape Indirect Bonding module. The models are created with a TRIOS intraoral scan or conventional impression scanned with a 3Shape dental lab scanner.
After treatment planning, the real American Orthodontic brackets are placed on the patient using transfer trays also designed with the 3Shape indirect bonding software and printed with a 3D printer.
“We are very excited about the exclusive integration with American Orthodontics and being the first indirect bonding solution used with their popular bracket systems,” says Allan Junge Hyldal, Vice President 3Shape Orthodontics.
“There are so many documented advantages to indirect bonding. Because of this, 3Shape is very active in building digital integrations with leading bracket libraries like American Orthodontics. We ensure that professionals using 3Shape orthodontic solutions have the largest selection of treatment opportunities for their patients.”
“We are pleased to become the largest and most comprehensive library available within 3Shape orthodontics and partner with them in providing orthodotnic labs and practices around the world with high quality digital treatment soloutions” says American Orthodontics Vice President of Marketing Michael Terrill