← Product Code [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR) · K944575

# AQUAFRESH PLAQUE FIGHTING GUM (K944575)

_Smithkline Beecham Consumer Healthcare Products · EJR · Dec 15, 1994 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K944575

## Device Facts

- **Applicant:** Smithkline Beecham Consumer Healthcare Products
- **Product Code:** [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR.md)
- **Decision Date:** Dec 15, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6030
- **Device Class:** Class 1
- **Review Panel:** Dental

## Regulatory Identification

An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

---

**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K944575](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K944575)

**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