Definition: For Use In Plastic And Reconstructive Surgery. The Devices Can Be Used For Cosmetic Augmentation And Corrections Of Soft Tissue Deformities In The Face, Including Areas Such As The Nose, Chin, And Cheeks.
| Device Type ID | 5795 |
| Device Name | Facial Implant |
| Physical State | Solid Implants |
| Technical Method | Plastic Surgery |
| Target Area | Face |
| Regulation Description | Polytetrafluoroethylene With Carbon Fibers Composite Implant Material. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3500 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ODU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5795 |
| Device | Facial Implant |
| Product Code | ODU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Polytetrafluoroethylene With Carbon Fibers Composite Implant Material. |
| CFR Regulation Number | 878.3500 [🔎] |
| Device Problems | |
|---|---|
Failure To Osseointegrate | 1 |
| Total Device Problems | 1 |