eCFR Reference Browser

---

title: "21 CFR §872.3660"

source: "https://www.ecfr.gov/current/title-21/section-872.3660"

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: "872.3660"

section_subject: "Impression material."

cfr_reference: "21 CFR 872.3660"

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. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

(b)Classification. Class II (Special Controls).

§872.3660 - Impression material.