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U.S. Department of Health and Human Services

Product Classification
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Device over the counter electrical salivary stimulatory system
Regulation Description Electrical salivary stimulatory system.
Definition Over the Counter Device intended to electrically stimulate a relative increase in saliva production
Physical State Intraoral device with battery
Technical Method Promote salivary function by mechanical and electrical stimulation of nerves that are involved in the salivary reflex
Target Area Intraoral
Regulation Medical Specialty Dental
Review Panel Dental
Product CodeQTT
Premarket Review Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Division of Dental and ENT Devices (DHT1B)
Submission Type 510(k)
Regulation Number 872.5560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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