Title 21: Food and Drugs
« Home / Title 21 - Food and Drugs--Volume 8 / CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) / SUBCHAPTER H - MEDICAL DEVICES
/ PART 872 - DENTAL DEVICES
/ Subpart D - Prosthetic Devices / § 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
§ 872.3410 Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.
(a) Identification. An ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive is a device containing ethylene oxide homopolymer and/or carboxymethylcellulose sodium intended to be applied to the base of a denture before the denture is inserted in a patient's mouth to improve denture retention and comfort.
(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.