KXY · Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce

Dental · 21 CFR 872.3500 · Class 3

Overview

Product CodeKXY
Device NamePolyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce
Regulation21 CFR 872.3500
Device ClassClass 3
Review PanelDental

Identification

Polyvinylmethylether maleic anhydride (PVM-MA), acid copolymer, and carboxymethylcellulose sodium (NACMC) denture adhesive is a device composed of polyvinylmethylether maleic anhydride, acid copolymer, and 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.

Classification Rationale

Class III.

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Innolitics

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