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Are Clear Teeth Aligners FDA-Approved?

By WebMD Connect to Care Staff
Clear plastic teeth aligners are FDA-approved. Learn more about dental aligner safety and how to use them to straighten teeth.

Dental aligners approved by the U.S. Food and Drug Administration (FDA) offer an effective and relatively comfortable way to straighten teeth, as long as they are used as prescribed.

Are Dental Aligners FDA-Approved?

Clear dental aligners are designated by the FDA as Class II medical devices that require a prescription. The requirement for a prescription protects consumers by ensuring that the aligners are being used safely and for their intended purposes.

“Many of the most popular aligner providers are certified and approved by the American Dental Association and the Food and Drug Administration,” Peter Guirguis, DDS, owner of Definitive Dental, tells WebMD Connect to Care. “However, there are companies that advertise similar treatment programs without the supervision of a dentist or orthodontist. The only safe way to straighten teeth is under the care of a dentist or orthodontist.”

How Dental Aligners Straighten Teeth

Like traditional braces, dental aligners apply pressure to your teeth to gradually move them into the desired positions. Dental aligners are custom-made to fit over your teeth, have less of an impact on your quality of life than traditional braces, and are relatively comfortable.

At the beginning of your aligner treatment, you’ll typically create an impression of your teeth using materials that your aligner company will send to you. Dental professionals will then use your impressions to create a straightening treatment plan specific to you. 

You’ll be able to communicate with your provider throughout the treatment as dentists or orthodontists monitor your progress. Your provider will send a series of aligners directly to you, and each set will gradually shift your teeth into proper alignment in a step-by-step process. 

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