Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3400](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3400) → KOM — Adhesive, Denture, Acacia And Karaya With Sodium Borate

# KOM · Adhesive, Denture, Acacia And Karaya With Sodium Borate

_Dental · 21 CFR 872.3400 · Class 1_

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

## Overview

- **Product Code:** KOM
- **Device Name:** Adhesive, Denture, Acacia And Karaya With Sodium Borate
- **Regulation:** [21 CFR 872.3400](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3400)
- **Device Class:** 1
- **Review Panel:** [Dental](/submissions/DE)

## Identification

A karaya and sodium borate with or without acacia denture adhesive is a device composed of karaya and sodium borate with or without acacia intended to be applied to the base of a denture before the denture is inserted into patient's mouth to improve denture retention and comfort.

## Classification Rationale

(1) Class I (general controls) if the device contains less than 12 percent by weight of sodium borate. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(2) Class III if the device contains 12 percent or more by weight of sodium borate.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K910216](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOM/K910216.md) | STEADFAST DENTURE ADHESIVE POWDER | Stiefel Research Institute, Inc. | Mar 29, 1991 | SESE |

## Top Applicants

- Stiefel Research Institute, Inc. — 1 clearance

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

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