BioMeDevice Ltd. today announced that it has received FDA approval to market the new and innovative gumEase Cryo-Anesthetic dental mouthpiece to US dental practitioners and over the counter across the United States. The easy-to-use, disposable device is a breakthrough in pain management. Inserted into the sulci above and below the upper and lower gums, the latex-free device delivers anesthetic pain relief to the maxillofacial nerves, quickly diminishing pain. In patient testing the new gumEase diminished pain by 90% in 3 to 4 minutes for the average participant.The gumEase is a sterile device made of biocompatible ThermoPlastic Elastomer (TPE) containing a saline solution. A `standalone` device, gumEase is not connected or supported by any other means. The device is chilled in a temperature controlled freezer, and as soon as the device is placed in the proper sulci of the mouth, the cooling transfer begins – with a surprisingly powerful effect on patient pain relief. Possible side effects associated with the use of gumEase is the potentiality that the cryotherapy will not have a totally and comprehensive disruption of oral pain.