title: Dental Devices; Reclassification of Electrical Salivary   Stimulator System. Final order.
abstract: The Food and Drug Administration (FDA) is issuing a final order to reclassify the salivary stimulator system, a postamendments Class III device, into class II (special controls) and to rename the device the "electrical salivary stimulator system." 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.
mesh_terms: D003748:Dental Equipment / Q000145:classification*; D003813:Dentistry; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004599:Electric Stimulation Therapy / Q000145:classification* / Q000295:instrumentation*; D004869:Equipment Safety / Q000145:classification*; D006801:Humans; D012463:Saliva; D012472:Salivation; D014481:United States