| Device Type ID | 1157 |
| Device Name | Toothbrush, Manual |
| Regulation Description | Manual Toothbrush. |
| 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) Exempt |
| CFR Regulation Number | 872.6855 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | EFW |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1157 |
| Device | Toothbrush, Manual |
| Product Code | EFW |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Manual Toothbrush. |
| CFR Regulation Number | 872.6855 [🔎] |
| Device Problems | |
|---|---|
Detachment Of Device Component | 4 |
Product Quality Problem | 4 |
Device Operates Differently Than Expected | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Material Separation | 2 |
Out-Of-Box Failure | 1 |
Material Fragmentation | 1 |
Component Falling | 1 |
Manufacturing, Packaging Or Shipping Problem | 1 |
Break | 1 |
Use Of Device Problem | 1 |
Device Dislodged Or Dislocated | 1 |
Fracture | 1 |
| Total Device Problems | 24 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Norwex Usa Inc | II | Feb-26-2015 |