eCFR Reference Browser

---

title: "21 CFR §872.3520"

source: "https://www.ecfr.gov/current/title-21/section-872.3520"

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: "872.3520"

section_subject: "OTC denture cleanser."

cfr_reference: "21 CFR 872.3520"

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 OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.

(b)Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

§872.3520 - OTC denture cleanser.