← Product Code [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR) · K940496

# PROPHY PASTE (K940496)

_Challenge Products, Inc. · EJR · Apr 19, 1994 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K940496

## Device Facts

- **Applicant:** Challenge Products, Inc.
- **Product Code:** [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR.md)
- **Decision Date:** Apr 19, 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).

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K940496](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K940496)

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