KOJ · Airbrush
Dental · 21 CFR 872.6080 · Class 2
Overview
| Product Code | KOJ |
|---|---|
| Device Name | Airbrush |
| 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 (20 of 48)
Showing 20 most recent of 48 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251425 | turbodent touch | Mectron S.P.A. | May 9, 2025 | SESE |
| K063236 | BETA-POWDER | Brainbase Corporation | Feb 16, 2007 | SESE |
| K042872 | RONDOFLEX PLUS 360 | Kavo America Corporation | Nov 23, 2004 | SESE |
| K033675 | PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER | Sirona Dental Systems GmbH | Jan 15, 2004 | SESE |
| K033215 | PREPAIR | Danville Materials, Inc. | Jan 9, 2004 | SESE |
| K024105 | VELOPEX AQUACUT FLUID ABRASION UNIT | Velopex International, Inc. | Oct 9, 2003 | SESE |
| K030292 | GROMAN PREPMASTER | Groman, Inc. | Apr 15, 2003 | SESE |
| K021450 | CLINPRO PROPHY POWDER | 3M Espe AG Dental Products | Aug 1, 2002 | SESE |
| K014188 | NEW PROPHY POWDER | Dentsply Intl. | Mar 15, 2002 | SESE |
| K014252 | JETSTREAM | Deldent , Ltd. | Feb 19, 2002 | SESE |
| K014249 | JETPOLISHER | Deldent , Ltd. | Feb 19, 2002 | SESE |
| K014245 | JETSONIC 2000 | Deldent , Ltd. | Jan 29, 2002 | SESE |
| K013969 | MINIBLASTER | Deldent , Ltd. | Jan 10, 2002 | SESE |
| K993182 | DISPOPROPHY | Kis Products | Aug 6, 2001 | SESE |
| K993124 | DISPODRILL | Kis Products | Aug 6, 2001 | SESE |
| K984380 | DISPO ETCH | Kis Products | Aug 6, 2001 | SESE |
| K010816 | DENTO-PREP PARTICLE MICROBLASTER | Ronvig A/S | May 10, 2001 | SESE |
| K002708 | KAVO CORUND HANDPIECE 2013 | Kavo America | Nov 28, 2000 | SESE |
| K990060 | MACH 7 | Kreativ, Inc. | Jun 15, 2000 | SESE |
| K001313 | AIRDENT II CS | Air Technologies, Inc. | Jun 8, 2000 | SESE |
Top Applicants
- Deldent , Ltd. — 4 clearances
- Kis Products — 3 clearances
- Kreativ, Inc. — 3 clearances
- Danville Engineering, Inc. — 2 clearances
- Young Dental Manufacturing Co. 1, LLC — 2 clearances
