| Device Type ID | 1251 |
| Device Name | Crown, Preformed |
| Regulation Description | Preformed Crown. |
| Regulation Medical Specialty | Dental |
| 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 | 510(K) Exempt |
| CFR Regulation Number | 872.3330 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ELZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 1251 |
| Device | Crown, Preformed |
| Product Code | ELZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Preformed Crown. |
| CFR Regulation Number | 872.3330 [🔎] |
| Device Problems | |
|---|---|
Hole In Material | 1 |
Material Perforation | 1 |
| Total Device Problems | 2 |