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U.S. Department of Health and Human Services

Product Classification

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Device intraoral pressure gradient device
Regulation Description Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
Definition This intraoral device is electrically powered and operates by reducing the pressure in the oral cavity (by way of tubing and a noninvasive oral interface) to create a continuous positive pressure gradient from the airway to the oral cavity that urges the soft palate and tongue forward.It is intended to be used while a patient is sleeping to treat obstructive sleep apnea.
Physical State Mouthpiece, Tubing, Negative Pressure Console
Technical Method Negative Pressure
Target Area Oral Cavity
Regulation Medical Specialty Dental
Review Panel Anesthesiology
Product CodeOZR
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
Respiratory Devices Branch (RPDB)
Submission Type 510(k)
Regulation Number 872.5570
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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