part_subject: "GENERAL AND PLASTIC SURGERY DEVICES"
subpart_code: "D"
subpart_subject: "Prosthetic Devices"
section_number: "878.3500"
section_subject: "Polytetrafluoroethylene with carbon fibers composite implant material."
cfr_reference: "21 CFR 878.3500"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
(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.