eCFR Reference Browser

---

title: "21 CFR §872.3630"

source: "https://www.ecfr.gov/current/title-21/section-872.3630"

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: "872.3630"

section_subject: "Endosseous dental implant abutment."

cfr_reference: "21 CFR 872.3630"

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. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

(b)Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)

§872.3630 - Endosseous dental implant abutment.