The U.S. Food and Drug Administration (FDA) issued a final order on November 20 to reclassify and rename what has been known as a salivary stimulator system.
The device will be known as an "electrical salivary stimulator system," according to the proposal in the Federal Register (September 18). The device will now be classified as class II (special controls) device. Previously it was a class III device. The order is effective December 21, 2015.
Twenty comments were provided during the comment period, which closed on December 17. The vast majority of the comments (17) were in favor of the reclassification.
In the September proposal, the FDA listed four potential health risks of the device:
- Hazards caused by electrical equipment
- Hazards caused by electromagnetic interference and electrostatic discharge
- Damage to intraoral tissue or dentition
- Adverse tissue reaction
"The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device," the FDA wrote.
The "FDA is identifying the device under this new name to distinguish it from other devices that stimulate saliva flow via nonelectrical means," the agency noted.
The electrical salivary stimulatory system device is now classified as a "prescription device restricted to patient use only upon the authorization of a dental practitioner or physician licensed by law to administer or use the device."
