Align Technology Receives 510(k) Clearance From the FDA For Invisalign Treatment

Align Technology (NASDAQ:ALGN) announced that the U.S. Food and Drug Administration (FDA) has cleared Invisalign treatment with mandibular advancement for commercial availability in the U.S.

As quoted in the press release:

“Class II malocclusion is the largest opportunity in the teen segment, representing close to 45% of the 9 million teen case starts worldwide each year,” said Raphael Pascaud, Align Technology chief marketing officer.  “We believe that Invisalign treatment with mandibular advancement offers significant benefits to both doctors and their patients and is an effective alternative for Class II elastics and other traditional functional appliances like twin blocks”.

In Class II treatments, doctors align the teeth and advance the lower jaw to improve the patient’s profile. Invisalign treatment with mandibular advancement is designed to replicate the action of commonly used functional appliances for Class II correction through new “precision wings” which hold the mandible in a forward position, while simultaneously correcting malocclusion and crowding issues. Traditionally, doctors often correct the mandible position and straighten the teeth in separate phases, resulting in a longer overall treatment time.

Click here to read the full press release.