| Device Type ID | 1312 |
| Device Name | Device, Anti-snoring |
| 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 | LRK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 1312 |
| Device | Device, Anti-snoring |
| Product Code | LRK |
| 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 | |
ALLEN J. MOSES, DDS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
AMERICAN DENTAL SLEEP MEDICINE, IP, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AMERICAN SLEEP DENTISTRY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
APNEA SCIENCES CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMODELING SOLUTIONS, LLS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BLUESOM | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COMFORT ACRYLICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CRANE DENTAL LABORATORY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DISTAR, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FIRMA INGEMARSSON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FUSELIER ENTERPRISES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GERGENS ORTHODONTIC LAB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSERT MOLDING SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTITUTE FOR QUALITY RESOURCE MANAGEMENT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICHAEL D. WILLIAMS,DDS PA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRODENTAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OVENTUS MANUFACTURING PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SICAT GMBH & CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SLEEPING WELL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SOMNOMED INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 45 |
Product Quality Problem | 10 |
Break | 8 |
Delamination | 7 |
Detachment Of Device Component | 6 |
Patient-Device Incompatibility | 2 |
Device Reprocessing Problem | 1 |
Fracture | 1 |
Migration Or Expulsion Of Device | 1 |
Device Appears To Trigger Rejection | 1 |
Use Of Device Problem | 1 |
Extrusion | 1 |
Material Fragmentation | 1 |
Material Protrusion / Extrusion | 1 |
Device Handling Problem | 1 |
Malposition Of Device | 1 |
| Total Device Problems | 88 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Respire Medical | II | May-29-2018 |