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) → KOP — Adhesive, Denture, Karaya

# KOP · Adhesive, Denture, Karaya

_Dental · 21 CFR 872.3450 · Class 1_

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

## Overview

- **Product Code:** KOP
- **Device Name:** Adhesive, Denture, Karaya
- **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 |
| --- | --- | --- | --- | --- |
| [K802285](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOP/K802285.md) | OHIO THORACIC SUCTION REGULATOR | Ohio Medical Products | Oct 3, 1980 | SESE |

## Top Applicants

- Ohio Medical Products — 1 clearance

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

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