The FDA approval comes as the company rolls out Release 11, its newest innovations and updates to the Spark Clear Aligner System. 

Ormco Corp has received FDA clearance to treat mixed dentition with its Spark Clear Aligner System, enabling orthodontists to treat younger patients. Coinciding with the clearance announcement is Release 11, the latest update to the Spark Clear Aligner System. 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% 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.” 

In addition, Rick Matty, vice president and general manager of digital solutions at Ormco, told Orthodontic Products, “The Spark Aligner System is an ideal solution for active kids’ and teens’ lifestyles. Our high-performance TruGEN material delivers more consistent force to more efficiently move teeth. Spark Aligners are also more stain-resistant (in case kids don’t take them out while drinking beverages), more comfortable, and more clear (so the treatment is less noticeable) than the leading aligner brand. Doctors can order free replacements for their young patients if one gets lost. Now, in Release 11, we are giving doctors even more flexibility and control in treating younger patients with specific features that accommodate for erupting teeth.”

According to the company, the anatomical beveled attachments included in Release 11 conform to the surface of each tooth to provide a more uniform active attachment surface and to minimize sharp edges for patient comfort; while the redesigned bite ramps reportedly 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. The Mixed detention support in the Approver software wgucg us also a part of Release 11, allows doctors to treat younger patients (kids and teens) with mixed dentition, including providing eruption guides for semi-erupted teeth and numbering primary teeth. 

Release 11 also gives users access to downloadable STL files. The first three stages and the last stage are now available for doctors to download from the Spark portal.

This latest release also includes enhancements to the Spark Approver software. Spark Approver reportedly 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. And 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 aimed at easier case management include new packaging improvements which 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 reportedly help ensure that aligner bags remain in order. In addition, a more efficient workflow through staff accounts will allow 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.