← Product Code [JER](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER) · K832387

# DENTURE CLEANER (K832387)

_Tower Laboratories, Ltd. · JER · Sep 12, 1983 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K832387

## Device Facts

- **Applicant:** Tower Laboratories, Ltd.
- **Product Code:** [JER](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER.md)
- **Decision Date:** Sep 12, 1983
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.3530
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

A mechanical denture cleaner is a device, usually AC-powered, that consists of a container for mechanically agitating a denture cleansing solution. The device is intended to clean a denture by submersion in the agitating cleansing solution in the container.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K832387](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/JER/K832387)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
