FDA ClassificationInvisalign is fully approved by the FDA as a Class II medical device. Under FDA classification, this type of aligner is classified as a "medical device" because it is an apparatus used to treat a condition.
Class II medical devices are subject to more regulation than Class I devices because of some potential for misuse; however, they are much safer than Class III devices. Unlike Class I devices, which require only general controls and the registration of the manufacturer, Class II devices are tested through a series of special controls that require outside examination by the FDA. This additional examination translates to greater confidence for the consumer of the device.
History of FDA ApprovalThe makers of this dental device, Align Technology, Inc, has received FDA approval to manufacture and sell its product since 1998. Align Technology has filed for and received FDA approval of subsequent modifications to the design, the most recent of which was in 2008.
Invisalign has over a decade of FDA approval and has been proven effective and safe through special testing and regulation.