Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3410](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3410) → KXW — Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer

# KXW · Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer

_Dental · 21 CFR 872.3410 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KXW

## Overview

- **Product Code:** KXW
- **Device Name:** Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer
- **Regulation:** [21 CFR 872.3410](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3410)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## Classification Rationale

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.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KXW](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KXW)

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