Definition: Foreign Dental Lab Manufactured Resin Restorations Are Permanent Restorations That Are Manufactured As Finished Products From Resins.
| Device Type ID | 1413 |
| Device Name | Restoration, Resin |
| 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 | NSM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1413 |
| Device | Restoration, Resin |
| Product Code | NSM |