Definition: Used For Dental Crown Restorations By Single Crown, Bridge, Etc, Or For Indirect Repair Of Dental Crown Fabrications.
Device Type ID | 1424 |
Device Name | Crown & Bridge Material, Resin Based |
Physical State | Used For Dental Crown Restorations By Single Crown, Bridge, Etc, Or For Indirect Repair Of Dental Crown Fabrications |
Technical Method | Used For Dental Crown Restorations By Single Crown, Bridge, Etc, Or For Indirect Repair Of Dental Crown Fabrications |
Target Area | Tooth |
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 | PKJ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 1424 |
Device | Crown & Bridge Material, Resin Based |
Product Code | PKJ |