What is Suresmile?

Suresmile uses 3-D computer imaging technology to depict the complete treatment plan from the initial position to the final desired position from which a series of custom-made, clear "aligners" are produced. Each "aligner" moves teeth incrementally and is worn for about two weeks, then replaced by the next in the series until the final position is achieved.

• Suresmile is clear. You can straighten your teeth without anyone knowing.

• Invisalign is removable. Unlike braces, you can eat and drink what you want during treatment. You can also brush and floss normally to maintain good oral hygiene.

• Invisalign is comfortable. There are no metal brackets or wires as with braces to cause mouth irritation, and no metal or wires means you spend less time in the doctor's chair getting adjustments.

• Invisalign allows you to view your own virtual treatment plan before you start so you can see how your straight teeth will look when your treatment is complete.

Aligners are made of clear, strong medical grade plastic that is virtually invisible when worn.

Aligners are clear and look similar to tooth-whitening trays, but are custom-made for a better fit to move teeth. Some orthodontists and dentists have referred to them as "contact lenses for teeth."

Align Technology, Inc., the company that manufactures Invisalign, was founded in 1997. Since then, Align has manufactured over 10,000,000 aligners and 250,000 patients have been in treatment.

In 1945, Dr. H.D. Kesling envisioned that one day modern technology would enable the use of a series of tooth positioners to produce the kinds of movements required for comprehensive orthodontic treatment. Technology has made this vision a reality. Using advanced computer technology, Align generates Suresmile®, a series of customized clear appliances, called "aligners." Each aligner is worn sequentially by the patient to produce extensive tooth movements in both upper and lower arches.

Worldwide, almost 250,000 patients have been treated with Suresmile. The number grows daily.

While Suresmile can be used with virtually any treatment philosophy, specific training is needed. All orthodontists and dentists interested in treating patients with Invisalign must attend training before cases will be accepted from their office. Close to 30,000 orthodontists and dentists worldwide are certified to use Invisalign.

Like brackets and arch wires are to braces, Suresmile aligners move teeth through the appropriate placement of controlled force on the teeth. The principal difference is that Invisalign not only controls forces, but also controls the timing of the force application. At each stage, only certain teeth are allowed to move, and these movements are determined by the orthodontic treatment plan for that particular stage. This results in an efficient force delivery system.

Yes, the FDA has reviewed our application and in August 1998 determined that Suresmile is exempt from 510(k) pre-market notification.