Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart G — Miscellaneous Devices](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices) → [21 CFR 872.6080](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6080) → PIP — Prophy Powder, Airbrush Accessory

# PIP · Prophy Powder, Airbrush Accessory

_Dental · 21 CFR 872.6080 · Class 2_

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

## Overview

- **Product Code:** PIP
- **Device Name:** Prophy Powder, Airbrush Accessory
- **Regulation:** [21 CFR 872.6080](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/872.6080)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)
- **3rd-party reviewable:** yes

## Identification

An airbrush is an AC-powered device intended for use in conjunction with articulation paper. The device uses air-driven particles to roughen the surfaces of dental restorations. Uneven areas of the restorations are then identified by use of articulation paper.

## Classification Rationale

Class II. The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

## Special Controls

The special control for this device is International Electrotechnical Commission's IEC 60601-1-AM2 (1995-03), Amendment 2, “Medical Electrical Equipment—Part 1: General Requirements for Safety.”

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K151748](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/PIP/K151748.md) | Clean & More | 3M Deutschland GmbH | Mar 11, 2016 | SESE |
| [K140684](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/PIP/K140684.md) | CLINPRO PROPHY POWDER | 3M Deutschland GmbH | Oct 24, 2014 | SESE |

## Top Applicants

- 3M Deutschland GmbH — 2 clearances

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

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