← Product Code [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR) · K002989

# PROCLUDE (K002989)

_Ortek Therapeutics, Inc. · EJR · Dec 14, 2000 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K002989

## Device Facts

- **Applicant:** Ortek Therapeutics, Inc.
- **Product Code:** [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR.md)
- **Decision Date:** Dec 14, 2000
- **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/K002989](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K002989)

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