| Device Type ID | 5608 |
| Device Name | Material, External Aesthetic Restoration, Used With Adhesive |
| Regulation Description | External Aesthetic Restoration Prosthesis. |
| 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 Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.3800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | GBI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5608 |
| Device | Material, External Aesthetic Restoration, Used With Adhesive |
| Product Code | GBI |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | External Aesthetic Restoration Prosthesis. |
| CFR Regulation Number | 878.3800 [🔎] |