← Product Code [EFW](/productcode/EFW) · K812364

# PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE (K812364)

_Jdm Commodities · EFW · Nov 20, 1981 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K812364

## Device Facts

- **Applicant:** Jdm Commodities
- **Product Code:** [EFW](/productcode/EFW.md)
- **Decision Date:** Nov 20, 1981
- **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/device/K812364](https://fda.innolitics.com/device/K812364)

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