Rocky Mountain Orthodontics (RMO), Denver, Colo, announced that Orthocaps® aligners have received clearance from the U.S. Food and 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.
According to RMO Chairman and CEO Tony Zakhem, more than 16,000 cases have been completed overseas using Orthocaps.
Orthocaps aligners feature a clear and aesthetic appearance, and a unique treatment program that is intended to improve clinical efficiency and results for even complex cases. The Orthocaps TwinAligner® system uses a daytime aligner for comfort and aesthetics, and a nighttime aligner for force-level customization and improved treatment efficiency. According to a press release from the company, this creates less material stress, is more hygienic, and reduces tray replacement costs.
The aligners feature a Dual Layer Polymer that is designed to deliver a soft inner tray for better grip and a firm outer tray for better force application.
The Orthocap TwinAligner system uses the digitized I-Setup, a virtual model to meet treatment preferences. This aligner system uses a thermoforming process to create a patient specific tray and includes a detailed 3D evaluation report to ensure treatment is progressing as planned after each treatment phase.
Orthocaps also feature pre-formed attachments that come with the aligner tray to reduce patient and staff chair time. Additionally, each aligner tray is hand-finished and polished for optimal fit along the gingival margin for patient comfort and appearance, according to the company. Orthocaps trays use a color-matching system to create an aligner that is “virtually invisible.”
