← Product Code [KOM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOM) · K910216

# STEADFAST DENTURE ADHESIVE POWDER (K910216)

_Stiefel Research Institute, Inc. · KOM · Mar 29, 1991 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOM/K910216

## Device Facts

- **Applicant:** Stiefel Research Institute, Inc.
- **Product Code:** [KOM](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOM.md)
- **Decision Date:** Mar 29, 1991
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3400
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOM/K910216](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/KOM/K910216)

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