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Has Invisalign been Approved by the FDA?

Has Invisalign been Approved by the FDA

Some products made for health and appearance are available despite lacking FDA approval. Fortunately, the Invisalign orthodontic system is not among them. This orthodontic system has been approved by FDA since 1998, providing safety and peace of mind for many dental patients. Here is more about the FDA approval of this treatment.

How Is Invisalign Classified by the FDA?

According to the FDA, Invisalign is classified as a Class II medical device. Class II means that in addition to complying with general controls, they also have special controls, such as mandatory performance Describing Invisalign aligners as medical devices might seem unusual at first glance, but their use in treating orthodontic medical conditions justifies their placement in this category. With its Class II status, Invisalign is recognized as having the potential to be misused. For this reason, Invisalign should only be administered by dentists with the training to do so properly.

Invisalign Approval Over the Years

Although the FDA first granted Class II approval to Invisalign almost 20 years ago, the orthodontic system has received updated approvals in the years since. Align Technology, the company behind Invisalign, has continually improved its system over the years and has received FDA approval with each change. The most recent Invisalign update was approved in 2008, ensuring that modern patients continue to have access to the latest Invisalign features.

Thus, it is good to know that FDA approval has been given to Invisalign and is continuously given as updates are provided to their system. Patients can have confidence in its safety and effectiveness when deciding that Invisalign treatment is right for them. Still, similar to all medical devices, it is most effective in the hands of a trained, experienced professional. At a consultation with our Invisalign dentist in Rocklin, Dr. Allen Sanders, patients can learn more about the approval of this treatment and the value of receiving it from a certified provider.


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