eCFR Reference Browser

---

title: "21 CFR §872.3645"

source: "https://www.ecfr.gov/current/title-21/section-872.3645"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "872"

part_subject: "DENTAL DEVICES"

subpart_code: "D"

subpart_subject: "Prosthetic Devices"

section_number: "872.3645"

section_subject: "Subperiosteal implant material."

cfr_reference: "21 CFR 872.3645"

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. Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.

(b)Classification. Class II.

§872.3645 - Subperiosteal implant material.