Definition: To Protect The Teeth And Reduce Damage Caused By Bruxing Or Nighttime Grinding And Prevention Of The Noise Associated With Bruxing And Grinding.
| Device Type ID | 1420 |
| Device Name | Mouthguard, Over-the-counter |
| Physical State | It Is A Material Similar To A Hard Methylmethacrylate Or A Softer Thermoplastic Resin. |
| Technical Method | The Dental Mouthguard Is A Removable Appliance That Is Fitted To The Teeth By Taking An Immpression Of The Teeth Or Using A Thermoplastic Resin |
| Target Area | Oral Cavity |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | OBR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1420 |
| Device | Mouthguard, Over-the-counter |
| Product Code | OBR |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BITE TECH INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
DENTEK ORAL CARE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GRIND GUARD TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTERNATIONAL PROFIT BUILDERS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PRESTIGE BRANDS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Delamination | 695 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Inadequacy Of Device Shape And/or Size | 3 |
Off-Label Use | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Use Of Device Problem | 2 |
Physical Property Issue | 1 |
Product Quality Problem | 1 |
Torn Material | 1 |
Misassembly By Users | 1 |
| Total Device Problems | 711 |