Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3490](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3490) → KOO — Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

# KOO · Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt

_Dental · 21 CFR 872.3490 · Class 1_

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

## Overview

- **Product Code:** KOO
- **Device Name:** Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
- **Regulation:** [21 CFR 872.3490](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3490)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## 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.

## 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 (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945200](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOO/K945200.md) | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES | Procter & Gamble Co. | Nov 30, 1994 | SESE |
| [K943486](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOO/K943486.md) | ORAFIX SPECIAL DENTURE ADHESIVE | Smithkline Beecham Corp. | Nov 3, 1994 | SESE |
| [K930335](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOO/K930335.md) | PROFAST - DENTURE ADHESIVE FOR LOWER JAWS | Fittydent-Altwirth & Schmitt GmbH | Feb 1, 1994 | SESE |
| [K862876](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOO/K862876.md) | NEW SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. | Aug 29, 1986 | SESE |

## Top Applicants

- Block Drug Company, Inc. — 1 clearance
- Fittydent-Altwirth & Schmitt GmbH — 1 clearance
- Procter & Gamble Co. — 1 clearance
- Smithkline Beecham Corp. — 1 clearance

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

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