FDA Warns Dental Device Maker Over Unapproved Use Ads

Law360, New York (April 17, 2012, 2:16 PM EDT) -- The U.S. Food and Drug Administration warned dental treatment manufacturer Myotronics-Noromed Inc. for advertising some of its products for unapproved uses, including treatment of sinus, cluster or migraine headaches, in a letter made public Tuesday.

The FDA's Center for Devices and Radiological Health Office of Compliance said it reviewed the company's print advertisements, brochures and websites promoting the K7 Evaluation System, the J5 Myomonitor and the BNS-40 muscle stimulator during an inspection of its Kent, Wash., facility last spring.

"FDA cleared the K7 Evaluation System for...
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