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Code · CFR · Title 21 — Food and Drugs · Part 872 — Dental Devices · § 872.3490

§ 872.3490. Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.

105 words·~1 min read·/us/cfr/t21/s§ 872.3490·

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(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]
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§ 872.3490
Carboxymethylcellulose sodium and/or polyvinylmethylether maleic acid calcium-sodium double salt denture adhesive.
Fed. Reg.×1
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