← Product Code [EFT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT) · K000996

# TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND (K000996)

_Dentsply Intl. · EFT · Jun 16, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K000996

## Device Facts

- **Applicant:** Dentsply Intl.
- **Product Code:** [EFT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT.md)
- **Decision Date:** Jun 16, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3520
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

An OTC denture cleanser is a device that consists of material in the form of a powder, tablet, or paste that is intended to remove debris from removable prosthetic dental appliances, such as bridges or dentures. The dental appliance is removed from the patient's mouth when the appliance is cleaned.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K000996](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K000996)

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