{"data":{"id":"us/21-cfr-878.3500","jurisdiction":"us","citation":"21 CFR 878.3500","heading":"Polytetrafluoroethylene with carbon fibers composite implant material.","body":"(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.\n(b) Classification. Class II.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 878—GENERAL AND PLASTIC SURGERY DEVICES","Subpart D—Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"ab9a93ff077fcc61fde05fc820199a74c48c6f62549b6adecf5e5e8dead8b0bd","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-878.3300","next":"us/21-cfr-878.3510"},"notice":"GroundRules: Original legal text. Not legal advice."}