Orthocaps® Aligners Receive FDA Clearance
DENVER, Oct. 23, 2018
DENVER, Oct. 23, 2018 /PRNewswire/ -- Rocky Mountain Orthodontics (RMO), an innovator of products and services for the orthodontic industry since 1933, announces that Orthocaps® aligners have received clearance from the U.S. Food & Drug Administration (FDA).
The FDA 510(k) Premarket Notification clearance enables Orthocaps® aligners to be commercially available throughout the United States. Orthocaps® aligners, manufactured by Ortho Caps GmbH, Hamm, Germany, are exclusively distributed in the United States and Canada through RMO.
Dr. Wajeeh Khan, managing director and founder of Ortho Caps, and a practicing orthodontist, says that the U.S. market needs an alternative aligner system. "We have devoted our efforts to create a technologically-advanced system that delivers impressive results with greater efficiency, while focusing on patient comfort and outstanding aesthetics," Khan says.
"With FDA clearance, we can now introduce to U.S. doctors and patients a truly unique and superb aligner treatment option solution," says RMO Chairman and CEO Tony Zakhem. "More than 16,000 successful, completed cases overseas, many involving complex movement, speaks to the versatility and effectiveness of Orthocaps®."
Orthocaps® aligners have a distinctively clear and aesthetic appearance, and a unique treatment program produces clinical efficiency and results for even complex cases. An innovative Dual Layer Polymer delivers a soft inner tray for better grip and a firm outer tray for better force application.
Unlike other aligner systems, the Orthocaps® TwinAligner® system uses a daytime aligner for comfort and aesthetics, and a nighttime aligner for force-level customization and improved treatment efficiency. This creates less material stress, is more hygienic and reduces tray replacement costs.
The digitized I-Setup is a virtual model that meets treatment preferences, ensuring accuracy and correct treatment plans, eliminating the time-consuming "back and forth" doctors experience with other aligner setups. Unlike other aligners, the thermoforming process creates a precise patient-specific tray that is more comfortable and clearer. A detailed 3-D evaluation report ensures treatment is progressing as planned after each treatment phase.
Another distinctive feature of Orthocaps® is the pre-formed attachments that come with the aligner tray. This reduces patient chair time by making the bonding process faster and easier for staff. Each aligner tray is hand-finished and polished for optimal fit along the gingival margin for patient comfort and appearance. With its color-matching system, Orthocaps® trays are virtually invisible.
To learn more about Orthocaps® aligners, visit www.orthocaps.com or contact Shane Burden, North American Orthocaps Manager, at 800.525.6044 ext. 8466.
About Ortho Caps, GmbH
Ortho Caps GmbH is a privately-owned German dental product company with headquarters in Hamm/Westphalia, Germany. The company designs, engineers, manufactures and distributes clear orthodontic aligners to 35 countries. The company was founded by orthodontist Dr. Wajeeh Khan in 2006.
About Rocky Mountain Orthodontics (RMO)
Celebrating its 85th year, Rocky Mountain Orthodontics (RMO) is a privately-held and operated company headquartered in Denver, Colo., led by Tony Zakhem and Jody Hardy. RMO is on the forefront of engineering, manufacturing and distribution of innovative, high-quality orthodontic products and services. Through its distribution network, RMO orthodontic products are sold in nearly 70 countries worldwide and has a wholly-owned subsidiary in Strasbourg, France, that has been distributing Orthocaps® aligners for four years. Visit www.rmortho.com to learn more.
Marketing Manager | Rocky Mountain Orthodontics
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SOURCE Rocky Mountain Orthodontics