Definition: PMA To Be Filed By 3/30/99 (63 FR 71746 (12/30/98))
| Device Type ID | 1325 |
| Device Name | Mandibular Condyle Prosthesis |
| Regulation Description | Mandibular Condyle Prosthesis. |
| 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 | PMA |
| CFR Regulation Number | 872.3960 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MPL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1325 |
| Device | Mandibular Condyle Prosthesis |
| Product Code | MPL |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Mandibular Condyle Prosthesis. |
| CFR Regulation Number | 872.3960 [🔎] |