← Product Code [EFS](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS) · K831321

# GUM MACHINE (K831321)

_The Gum Machine Co. · EFS · Jul 7, 1983 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K831321

## Device Facts

- **Applicant:** The Gum Machine Co.
- **Product Code:** [EFS](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS.md)
- **Decision Date:** Jul 7, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6510
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

An oral irrigation unit is an AC-powered device intended to provide a pressurized stream of water to remove food particles from between the teeth and promote good periodontal (gum) condition.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K831321](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EFS/K831321)

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