Definition: Foreign Dental Lab Manufactured Orthodontic Prosthesis Are Finished Custom-fit Orthodontic Prosthesis.
| Device Type ID | 1418 |
| Device Name | Prosthesis, Orthodontic |
| 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 | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | NSR |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1418 |
| Device | Prosthesis, Orthodontic |
| Product Code | NSR |