← Product Code [MCF](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MCF) · K003517

# OTRES TOOTHBRUSH SANITIZER MODEL TB100W (K003517)

_Otres, LLC · MCF · Jun 6, 2001 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MCF/K003517

## Device Facts

- **Applicant:** Otres, LLC
- **Product Code:** [MCF](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MCF.md)
- **Decision Date:** Jun 6, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6855
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MCF/K003517](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/MCF/K003517)

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