Definition: For The Treatment Of Night Time Snoring And Mild To Moderate Obstructive Sleep Apnea In Patients 18 Years Of Age Or Older While Also Measuring Patient Compliance To Oral Appliance Therapy.
| Device Type ID | 1381 |
| Device Name | Sleep Appliances With Patient Monitoring |
| Physical State | Comprised Of Two Customized Splints (upper And Lower) Held Together By A Locking Mechanism |
| Technical Method | Advances The Patient's Mandible In A Forward Position To Increase Airway Space And Additionally Monitors The Patient Compliance To Oral Appliance Therapy |
| Target Area | Patient's Oral Cavity |
| Regulation Description | Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea. |
| Regulation Medical Specialty | Dental |
| Review Panel | Dental |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) Dental Devices Branch (DEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 872.5570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1381 |
| Device | Sleep Appliances With Patient Monitoring |
| Product Code | PLC |
| 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 | |
AIRWAY MANAGEMENT, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRODENTAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOMNOMED INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |