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
| Device Type ID | 215 |
| Device Name | Intraoral Pressure Gradient Device |
| Physical State | Mouthpiece, Tubing, Negative Pressure Console |
| Technical Method | Negative Pressure |
| Target Area | Oral Cavity |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| Regulation Medical Specialty | Dental |
| Review Panel | Anesthesiology |
| 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) |
| CFR Regulation Number | 872.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OZR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 215 |
| Device | Intraoral Pressure Gradient Device |
| Product Code | OZR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| CFR Regulation Number | 872.5570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APNICURE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |