---
kind: "section"
citation: "21 C.F.R. § 878.3500"
title: "21"
number: "878.3500"
heading: "Polytetrafluoroethylene with carbon fibers composite implant material."
url: "https://uscodex.org/cfr/21/878.3500"
---

# §878.3500. Polytetrafluoroethylene with carbon fibers composite implant material.

- (a) **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.
- (b) **Classification.** Class II.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 53 FR 23872, June 24, 1988, unless otherwise noted.