← Product Code [EFT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT) · K860118

# SUNBEAM ULTRASONIC DENTURE CLEANER MODEL 4220 (K860118)

_Northern Electric Co. Div. of Sunbeam Corp. · EFT · Apr 17, 1986 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K860118

## Device Facts

- **Applicant:** Northern Electric Co. Div. of Sunbeam Corp.
- **Product Code:** [EFT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT.md)
- **Decision Date:** Apr 17, 1986
- **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/K860118](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K860118)

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