The U.S. FDA has cleared new labeling for Align Technology's Invisalign system, removing the permanent dentition limitation from the indications for use, according to the company. In addition, 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 Align Technology President and CEO Thomas Prescott in a press release. "Their clinical successes, along with our manufacturing and process improvements, have enabled us to amend our product labeling to reflect this broader applicability."
In 1998, the FDA cleared the Invisalign system for use in patients with permanent teeth and 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, according to the company.
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