PIP · Prophy Powder, Airbrush Accessory
Dental · 21 CFR 872.6080 · Class 2
Overview
| Product Code | PIP |
|---|---|
| Device Name | Prophy Powder, Airbrush Accessory |
| Regulation | 21 CFR 872.6080 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 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 | Clean & More | 3M Deutschland GmbH | Mar 11, 2016 | SESE |
| K140684 | CLINPRO PROPHY POWDER | 3M Deutschland GmbH | Oct 24, 2014 | SESE |
Top Applicants
- 3M Deutschland GmbH — 2 clearances
