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,” Dr. 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 Mr. 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 customisation and improved treatment efficiency. This creates less material stress, is more hygienic and reduces tray replacement costs.
The digitised 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 3D 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.
