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) → KOT — Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

# KOT · Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium

_Dental · 21 CFR 872.3490 · Class 1_

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

## Overview

- **Product Code:** KOT
- **Device Name:** Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium
- **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 (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K945462](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K945462.md) | SUPER POLI-GRIP DENTURE ADHESIVE CREAM | Block Drug Company, Inc. | Dec 20, 1994 | SESE |
| [K941365](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K941365.md) | MPI DENTURE ADHESIVE FILM SEALS | Medical Polymers, Inc. | Apr 22, 1994 | SESE |
| [K903568](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K903568.md) | SUPER STRENGTH DENTURE ADHESIVE CREAM | Teledyne Getz | Oct 24, 1990 | SESE |
| [K895818](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K895818.md) | STEADFAST DENTURE ADHESIVE CREAM | Stiefel Research Institute, Inc. | Apr 3, 1990 | SESE |
| [K884357](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K884357.md) | PRECISION BIOPORT COLLECTION & TRANSPORT SYSTEM | Precision Dynamics Corp. | Nov 1, 1988 | SESE |
| [K872225](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K872225.md) | SUPER POLI-GRIP & WERNET'S DENTURE ADHES. POWDER | Block Drug Company, Inc. | Jun 30, 1987 | SESE |
| [K854430](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K854430.md) | RIGIDENT CREAM | Armkel, LLC | Mar 4, 1986 | SESE |
| [K831493](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOT/K831493.md) | DENTURE ADHESIVE SEALS | Johnson & Johnson Professionals, Inc. | Jun 30, 1983 | SESE |

## Top Applicants

- Block Drug Company, Inc. — 2 clearances
- Armkel, LLC — 1 clearance
- Johnson & Johnson Professionals, Inc. — 1 clearance
- Medical Polymers, Inc. — 1 clearance
- Precision Dynamics Corp. — 1 clearance

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

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