Insignia™ Advanced Smile Design Receives FDA 510(k) Clearance For Faster, More Predictable Orthodontic Treatment

Latest Technology Combines 3-D Software with Customized Appliances for Image-Conscious Adults and Teens

ORANGE, Calif., Aug. 16, 2012 /PRNewswire/ -- Ormco Corporation, a leading manufacturer and provider of advanced orthodontic technology, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Insignia™, a combination of powerful 3-D treatment planning software and customized appliances that enable orthodontists to provide faster treatment and more predictable results compared with traditional braces.

To view the multimedia assets associated with this release, please click

Insignia is the only system that offers a variety of treatment choices ranging from traditional metal braces to Clearguide™ aligners or even Ormco's virtually invisible Damon Clear™ tieless braces.

Insignia's 3-D treatment software allows doctors to re-engineer a patient's smile and occlusion based on his or her unique dental anatomy, visually sharing the final result prior to the patient starting treatment.

"More than 23 million American adults want to improve their smiles but don't do so because they believe orthodontic treatment takes too long, is too painful and means a mouth full of metal," said Vicente Reynal, president of Ormco. "During clinical evaluations, doctors were able to finish many difficult cases in as little as 12 months with truly amazing results. Plus, image-conscious patients can be treated using aligners or clear, tieless braces depending on the severity of the case."

By integrating both 3-D treatment planning software and customized appliances, Insignia helps orthodontists deliver a quick and convenient course of treatment in fewer office visits.

Using a high-resolution scan, Insignia creates a precise 3-D virtual model of each patient's smile. With the digital rendering, doctors can modify the smile and occlusion, providing the patient with a preview of what their new smile will look like. Appliances are then customized to deliver the exact result for that specific patient.

"Because everything is customized for each patient, Insignia means fewer office visits and perfectly aligned teeth in treatment periods that were unheard of just a few years ago," said Jeff Kozlowski, DDS, an orthodontic specialist with offices in New London and East Lyme, Conn. "Insignia allows me to provide my patients with a better end result with fewer appointments and shorter overall treatment time. That makes my patients very happy."

For more information about Insignia or to locate an Insignia doctor, visit Media interested in speaking with an Ormco spokesperson should contact Robin Dwyer at 619-234-0345 or [email protected].  Connect on Facebook at, or Twitter at @Ormco.

About Ormco 

Ormco is dedicated to manufacturing innovative products that improve the clinician's opportunity to achieve excellent results in the least amount of time, in the fewest number of appointments, and with the greatest patient comfort. From personalized service to worldwide continuing education programs and marketing support, Ormco is committed to helping orthodontists achieve their clinical and practice management objectives. For more information, visit the Ormco website.


Robin Dwyer
[email protected]

SOURCE Ormco Corporation