← Product Code [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR) · K962370

# PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE (K962370)

_Challenge Products, Inc. · EJR · Mar 31, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K962370

## Device Facts

- **Applicant:** Challenge Products, Inc.
- **Product Code:** [EJR](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR.md)
- **Decision Date:** Mar 31, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6030
- **Device Class:** Class 1
- **Review Panel:** Dental

## Indications for Use

The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

## Device Story

Prophy paste; used by dental professionals; removes materia alba, plaque, and resistant stains from tooth surfaces; applied during routine dental cleaning procedures; aids in oral hygiene maintenance.

## Clinical Evidence

No clinical data; safety assessment based on review of 11 MDR records for product code EJR, identifying minimal adverse events related to prophy paste.

## Technological Characteristics

Prophy paste formulation; abrasive material for dental cleaning.

## 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).

## Predicate Devices

- Challenge Products, Inc. Prophy Paste ([K940496](/device/K940496.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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MAR 31 1997

# I. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

K962370

## 1. Name and Address

This Summary of Safety and Effectiveness is being submitted by Challenge Products, Inc., Lake Road 54-22 P.O. Box 468, Osage Beach, Missouri 65065.

## 2. Name of the Device

The device is generally known as a prophy paste.

## 3. Identification of Predicate Device(s)

Challenge Products, Inc. Prophy Paste, FDA control number K940496.

## 4. Description of the Device

The device is a prophy paste which is used by dental professionals to help remove resistant stains from the surface of the teeth.

## 5. Intended Use of the Device

The intended use of the prophy paste is to help remove materia alba, plaque and resistant stains from the teeth.

## 6. Comparison of Technological Characteristics

The differences between Challenge's new prophy paste and the predicate device are minor and do not impact the safety and effectiveness of the device in any significant way.

## 7. Safety

Challenge reviewed the 11 MDR records filed with CDRH relating to FDA's product code,"EJR" which were obtained from a CD-ROM database¹. Most of the events occurred as a result from an allergic or adverse reaction to a prophy

¹ The Medical Device Library, IHS Regulatory Products, 15 Inverness Way East, Englewood, CO 80150.

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jet powder. 3 of the 11 reports were filed for a prophy paste and 1 report was on a patient with a history of allergies. These reports follow.

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K962370](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/EJR/K962370)

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