21 CFR 878.3500 — Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent
General, Plastic Surgery (SU) · Part 878 Subpart D—Prosthetic Devices · § 878.3500
Identification
A polytetrafluoroethylene with carbon fibers composite implant material is a porous device material intended to be implanted during surgery of the chin, jaw, nose, or bones or tissue near the eye or ear. The device material serves as a space-occupying substance and is shaped and formed by the surgeon to conform to the patient's need.
Classification Rationale
Class II.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| ESF | Polymer, Composite Synthetic Ptfe With Carbon-Fiber, Ent | 2 | 2 | Implant |
| KDA | Prosthesis, Ptfe/Carbon-Fiber | 2 | 1 | Implant |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 2 | 25 | Implant |
| ODU | Facial Implant | 2 | 1 | Implant |
