(a)Identification. A carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive is a device composed of carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt 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.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63008, Dec. 7, 1994; 66 FR 38798, July 25, 2001]
Title 21 published on 2014-04-01
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