View all text of Subpart D [§ 872.3060 - § 872.3980]
§ 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.