| Device Type ID | 1140 |
| Device Name | Setter, Band, Orthodontic |
| Regulation Description | Dental Hand Instrument. |
| 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 | 872.4565 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ECR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |