Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3450](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3450) → KXX — Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer

# KXX · Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer

_Dental · 21 CFR 872.3450 · Class 1_

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

## Overview

- **Product Code:** KXX
- **Device Name:** Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer
- **Regulation:** [21 CFR 872.3450](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3450)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

Ethylene oxide homopolymer and/or karaya denture adhesive is a device composed of ethylene oxide homopolymer and/or karaya 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 if the device is made of wax-impregnated cotton cloth that the patient applies to the base or inner surface of a denture before inserting the denture into the mouth. The device is intended to be discarded following 1 day's use. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K863375](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KXX/K863375.md) | SEA-BOND | Combe, Inc. | Sep 19, 1986 | SESE |

## Top Applicants

- Combe, Inc. — 1 clearance

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

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