Aribex FDA

Aribex, Inc., clarified on Feb. 10, 2012, that the company's Nomad handheld X-ray devices was not under investigation by the U.S. Food and Drug Administration (FDA), which had announced that it was scrutinizing the illegal online sales of handheld dental and veterinary X-ray units by manufacturers outside the United States.

Aribex, which is based in Orem, Utah, said the FDA has previously cleared the Nomad as being safe for intended uses in all states.

In a statement, Ken Kaufman, Aribex president and CFO, said, “Clinician and patient safety has always been our number-one priority in developing and distributing our handheld X-ray device, and we are disappointed to learn that other manufacturers may not share a similar perspective. Just as the FDA fulfills its responsibilities, Aribex is equally committed to its role as the pioneer of safe and effective, battery-powered, handheld x-ray systems.

“We support the FDA in their efforts to warn and protect, and we follow their message with one of our own: we ask dentists, hygienists, veterinarians and other certified radiation operators to understand that rapidly changing technology has made it possible for handheld x-ray systems to be both safe and effective. Not only is the Nomad safe, patients and users have found that it improves their imaging experience.”

Aribex said its X-ray products meets FDA requirements, including FDA 510(K) clearance and labeling. Company officials cited a Washington State Department of Health study that was referenced by the FDA, determining Nomad to be safe. Aribex maintained that the Nomad systems are superior in their shielding and cone design characteristics when compared to any other intraoral dental X-ray system.

The company offered a $200 trade-up rebate on the purchase of a Nomad to replace an illegal device. For more information on this rebate, practitioners should contact Aribex at (866) 340-5522 or visit www.aribex.com.