Spark Clear Aligners Receive New FDA Approval

Posted: July 8, 2021
Edited by Orthotown staff

BREA, Calif.—Ormco recently announced that it has received FDA clearance to treat mixed dentition with its Spark Clear Aligner System, enabling orthodontists to treat younger patients. The FDA clearance makes Spark Clear Aligners one of a few doctor-directed aligners cleared in the U.S. for the treatment of younger patients.

The new Release 11 features new innovations and an improved user experience including new anatomical beveled attachments for patient comfort, redesigned bite ramps that enable doctors to customize for each specific tooth type to enhance engagement between the bite ramps and the teeth and downloadable STL files to offer doctors in-office solutions.

“With more than 75 percent of orthodontic case starts each year being kids and teens, we are excited that we can now enable doctors to offer the same innovative benefits of Spark treatment to younger patients,” said Eric Conley, president of Spark Clear Aligners and Digital Orthodontics. “We are also confident the advancements of this new release will solidify Spark as the aligner of choice for orthodontists seeking great clinical outcomes and providing industry leading comfort and clarity for their patients.” 

Spark Clear Aligners Receive New FDA Approval

Release 11 key features enable improved clinical outcomes, more predictable and efficient treatment planning and greater patient comfort:

- Anatomical beveled attachments conform to the surface of each tooth to provide a more uniform active attachment surface and to minimize sharp edges for patient comfort. 
- Redesigned bite ramps enhance the engagement between the bite ramps and the teeth and enable doctors to customize bite ramps for each specific tooth (incisors, canines, premolars) so that the active surface is oriented parallel to the occlusal plane. The new bite ramps have been lab tested for strength and durability.
- Mixed detention support in the Approver software allows doctors to treat younger patients (kids and teens) with mixed dentition, including providing eruption guides for semi-erupted teeth and numbering primary teeth. 
- Downloadable STL files of the first three stages and the last stage are now available for doctors to download from the Spark portal.

Spark Release 11 includes the following Approver software enhancements: 

- Continued Evolution of CBCT integration based on doctor input. Spark Approver now features several new improvements for more seamless and effective integration of CBCT data for Spark Aligners. Additional diagnostic tools include a 2D clipping plane featuring multiple views, new tooth identification options, and enhanced CBCT performance and visual rendering.
- An enhanced tooth movement table now includes both crown and root movement values, as well as the addition of both tip and torque movement for intermediate and challenging movement.
- User interface improvements based on doctor input include a new preset for overjet, a new panel docking/undocking feature, redesigned and more friendly menu options, and simpler dialog boxes.

Enhancements for easier case management

- New packaging improvements require less storage by including more aligners per box and reduces packaging waste. The introduction of connected aligner bags and Spark Aligners’ packaging inserts will help ensure that aligner bags remain in order.
- More efficient workflow through staff accounts allows orthodontic team members the ability to submit and manage Spark Aligner patients through the Spark Portal and Approver software. Support for multiple billing addresses for practices that have multiple offices will be available in August 2021.
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