No poke, no pain. FDA-approved mouthpiece takes needles away from dental visits

Dental pain relief without drugs? The FDA says yes, recently certifying the first cryoanesthetic dental mouthpiece. The new gumEase® makes visits to the dentist a whole lot easier, eliminating the need for shots. It's big news for the millions who can't or don't wish to use conventional hypodermically-delivered anesthesia.

The easy-to-use, disposable device is inserted into the gums for a few minutes. After removal, the anesthetic effect lasts for up to twenty minutes - and can be repeated as needed. Patients can apply them post-operatively, and reuse without the side effects, nausea, or impairment of conventional anesthesia. In tests, 100% of patients had complete pain relief in just 2 to 3 minutes, regardless of severity.

"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 the developing world.

The gumEase® is stored in a conventional freezer until freezing temperature is reached. Proprietary solutions inside the mouthpiece prevent it from freezing, allowing it to form comfortably within the patient's mouth for several minutes. 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.




  Dec. 12, 2007
No poke, no pain. FDA-approved mouthpiece takes needles away from dental visits...

Nov. 5, 2007
FDA approves gumEase® Cryo-Anesthetic dental mouthpiece for relief of dental pain without drugs...

April 20, 2007
European CE Approval for gumEase® Cryoanesthetic Device...

May 17, 2006
CryoDevices to Begin Manufacturing Advanced, State-Of-The-Art Dental Anesthetic Device ...