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.
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Dental Devices; Reclassification of Electrical Salivary Stimulator System
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)...
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80 FR 72585
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“Dental Devices; Reclassification of Electrical Salivary Stimulator System,” thefederalregister.org (November 20, 2015), https://thefederalregister.org/documents/2015-29638/dental-devices-reclassification-of-electrical-salivary-stimulator-system.