Definition: Foreign Dental Lab Manufactured Base Metal Restorations Are Crowns, Bridges, Inlays, And Onlays That Are Manufactured As Finished Products From Base Metals.
Device Type ID | 1417 |
Device Name | Restoration, Base Metal |
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 | NSQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1417 |
Device | Restoration, Base Metal |
Product Code | NSQ |