| Device Type ID | 1271 |
| Device Name | Toothbrush, Powered |
| Regulation Description | Powered 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 | 872.6865 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JEQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1271 |
| Device | Toothbrush, Powered |
| Product Code | JEQ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Powered Toothbrush. |
| CFR Regulation Number | 872.6865 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
PROCTER & GAMBLE CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PROCTER & GAMBLE MFG. CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Missing Value Reason | 723 |
Break | 49 |
Patient Device Interaction Problem | 46 |
Appropriate Term/Code Not Available | 38 |
Adverse Event Without Identified Device Or Use Problem | 33 |
Temperature Problem | 15 |
Heads | 14 |
Detachment Of Device Or Device Component | 10 |
Detachment Of Device Component | 9 |
Loose Or Intermittent Connection | 7 |
Brush | 4 |
Fire | 4 |
Product Quality Problem | 2 |
Vibration | 2 |
Component Falling | 2 |
Insufficient Information | 2 |
Crack | 2 |
Overheating Of Device | 1 |
Device Slipped | 1 |
Disconnection | 1 |
Housing | 1 |
Rod | 1 |
Moisture Damage | 1 |
Mechanical Jam | 1 |
Sticking | 1 |
Flare Or Flash | 1 |
Battery | 1 |
Burst Container Or Vessel | 1 |
Use Of Device Problem | 1 |
Physical Property Issue | 1 |
Tip | 1 |
| Total Device Problems | 976 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ranir Corporation | II | Jan-17-2014 |