Definition: Foreign Dental Lab Manufactured Porcelain Restorations Are Full Porcelain Crown And Bridge Restorations That Are Manufactured As Finished Products From Porcelains.
| Device Type ID | 1416 |
| Device Name | Restoration, Porcelain |
| 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 | NSP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1416 |
| Device | Restoration, Porcelain |
| Product Code | NSP |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
| Total Device Problems | 1 |