Anna Werner, CBS News

FDA Said It Never Inspected Dental Lab That Made Controversial AGGA Device

Johns Dental Laboratories stopped making the Anterior Growth Guidance Appliance last year after a KFF Health News-CBS News investigation into allegations of patient harm. The company had “never” reported any complaints about its products to the FDA, according to the agency.

‘AGGA’ Inventor Testifies His Dental Device Was Not Meant for TMJ or Sleep Apnea

The FDA and Department of Justice are investigating the Anterior Growth Guidance Appliance, or “AGGA.” TMJ and sleep apnea patients have filed lawsuits alleging the device harmed them. Its inventor now says the AGGA was never meant for these ailments.