The FDA has cleared new labeling for the Invisalign system, removing the permanent dentition limitation from the indications for use. Additionally, certain conditions previously listed as contraindications will now be listed as precautions.
"Over the years, our customers have demonstrated that many different types of malocclusion can be effectively treated with Invisalign," said Thomas M. Prescott, president and CEO of Align Technology Inc. "Their clinical successes, along with our manufacturing and process improvements, have enabled us to amend our product labeling to reflect this broader applicability."
The Invisalign system was cleared by the FDA in 1998 for use in patients with permanent teeth. The FDA had contraindicated the device for patients presenting with mixed dentition, severe overbite, severe overjet, tooth malocclusion requiring surgical correction, adolescent patients with a skeletally narrow jaw, and adult patients with dental prosthetics/implants.
