Ethylene oxide homopolymer and/or carboxymethylcellulose sodium denture adhesive.

21 C.F.R. § 872.3410
in effectEffective: 2024-07-01
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(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.

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