← Product Code [EFT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT) · K930337

# PROFAST(R)-DENTURE CLEANSER (K930337)

_Fittydent-Altwirth & Schmitt GmbH · EFT · Sep 7, 1993 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K930337

## Device Facts

- **Applicant:** Fittydent-Altwirth & Schmitt GmbH
- **Product Code:** [EFT](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT.md)
- **Decision Date:** Sep 7, 1993
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K930337](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/EFT/K930337)

**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
