Dental pain relief in seconds without drugs? The FDA recently approved the first cryoanesthetic dental mouthpiece for the U.S. over-the-counter market. Used as a standalone or in conjunction with conventional anesthesia, gumEase® provides pain relief without the side effects or complications of drugs. It's a tempting solution for clinicians plagued with patient needle phobia, cardiac/other health conditions, allergic reactions and the complex issues of hypodermic delivery.

The easy-to-use, disposable device is a breakthrough in pain management. It's as effective as it is inexpensive. "A regional pain block is achieved by the local application of extreme cold via the gumEase® to the maxillofacial nerves. The nerve fibers are chilled/frozen and can no longer transmit pain impulses to the brain"-that's how the gumEase® works. Patients can apply them post-operatively as needed and reuse without side effects by storing in a household freezer in accordance with directions provided.

"It gives dentists an option they didn't have before," says Tay McClellan, BioMeDevice CTO. "They can manage patient pain easily in a wider range of situations. Now it's not a problem to have a patient who can't use drug-based anesthesia." The device also holds promise for situations where needle use is limited, such as Brazil, whose interest in the gumEase® is spurred by HIV initiatives there.

The gumEase® G100 is prepared by storing in a temperature controlled freezer until freezing temperature is reached. The mouthpiece is made of a proprietary noDOP PVC biocompatible compound allowing it to form comfortably within the patient's mouth. Then over the next few minutes the maxillofacial nerves, the primary pain receptors in the mouth, are essentially "put to sleep" even after warming to body temperature.

Developed in Laguna Hills, California, by BioMeDevice, gumEase® component parts are manufactured by four American companies and assembled in Ireland.