Definition: Foreign Dental Lab Manufactured Full Dentures Are Manufactured As Finished Products From Denture Resins.
Device Type ID | 1412 |
Device Name | Dentures, Full |
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 | NSL |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1412 |
Device | Dentures, Full |
Product Code | NSL |