Airbrush
FDA product code KOJ · Class II (moderate risk) · 21 CFR 872.6080 · Dental
48510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Deldent , Ltd. 4
- Kis Products 3
- Kreativ, Inc. 3
- Kavo America 2
- Young Dental Manufacturing Co. 1, LLC 2
- Danville Engineering, Inc. 2
- Dove Systems, Inc. 1
- Ultradent Products, Inc. 1
- Parkell, Inc. 1
- Bisco, Inc. 1
- Simplex Medical Systems, Inc. 1
- Crystal Mark, Inc. 1
- Hampton Research 1
- Buffalo Dental Mfg. Co., Inc. 1
- Gambro, Inc. 1
- Mectron S.P.A. 1
- Sunrise Technologies, Inc. 1
- Texas Airsonics, Inc. 1
- Solar Dental Co., Inc. 1
- Henry Schein, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251425 | turbodent touchKOJ · Traditional | Mectron S.P.A. | 05/09/2025SE |
| K063236 | Beta-PowderKOJ · Traditional | Brainbase Corporation | 02/16/2007SE |
| K042872 | Rondoflex Plus 360KOJ · Special | Kavo America Corporation | 11/23/2004SE |
| K033675 | Prosmile Air Polisher and Prophylaxis PowderKOJ · Traditional | Sirona Dental Systems GmbH | 01/15/2004SE |
| K033215 | PrepairKOJ · Traditional | Danville Materials, Inc. | 01/09/2004SE |
| K024105 | Velopex Aquacut Fluid Abrasion UnitKOJ · Traditional | Velopex International, Inc. | 10/09/2003SE |
| K030292 | Groman PrepmasterKOJ · Traditional | Groman, Inc. | 04/15/2003SE |
| K021450 | Clinpro Prophy PowderKOJ · Traditional | 3M Espe AG Dental Products | 08/01/2002SE |
| K014188 | New Prophy PowderKOJ · Traditional | Dentsply Intl. | 03/15/2002SE |
| K014252 | JetstreamKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
| K014249 | JetpolisherKOJ · Traditional | Deldent , Ltd. | 02/19/2002SE |
| K014245 | Jetsonic 2000KOJ · Traditional | Deldent , Ltd. | 01/29/2002SE |
| K013969 | MiniblasterKOJ · Traditional | Deldent , Ltd. | 01/10/2002SE |
| K993182 | DispoprophyKOJ · Traditional | Kis Products | 08/06/2001SE |
| K993124 | DispodrillKOJ · Traditional | Kis Products | 08/06/2001SE |
| K984380 | Dispo EtchKOJ · Traditional | Kis Products | 08/06/2001SE |
| K010816 | Dento-Prep Particle MicroblasterKOJ · Traditional | Ronvig A/S | 05/10/2001SE |
| K002708 | Kavo Corund Handpiece 2013KOJ · Traditional | Kavo America | 11/28/2000SE |
| K990060 | Mach 7KOJ · Traditional | Kreativ, Inc. | 06/15/2000SE |
| K001313 | Airdent II CSKOJ · Traditional | Air Technologies, Inc. | 06/08/2000SE |
| K980672 | Simplex Airbrator (SAB-7)KOJ · Traditional | Irt Management Corp. | 05/04/2000SE |
| K984415 | S.S. White Technologies, Models 6500-D,6500-E, and 6500-FKOJ · Traditional | S.S. White Technologies, Inc. | 09/29/1999SE |
| K990545 | Jetsonic 2000KOJ · Traditional | Sds Dental, Inc. | 08/11/1999SE |
| K981564 | Air Techniques' Airdent IIKOJ · Traditional | Air Techniques, Inc. | 09/24/1998SE |
| K974655 | Preptech(Tm) 200 Cavity Preparation SystemKOJ · Traditional | Prep Technology Corp. | 07/09/1998SE |
| K980216 | Kreativ Mach 5, Mach 5 Plus, Mach M, Mach 6KOJ · Traditional | Kreativ, Inc. | 06/16/1998SE |
| K974488 | Airprep System - Model 9001KOJ · Traditional | Asi Medical, Inc. | 05/26/1998SE |
| K980726 | Ultra-BlasterKOJ · Traditional | Ultradent Products, Inc. | 05/12/1998SE |
| K973679 | AeroetcherKOJ · Traditional | Parkell, Inc. | 03/10/1998SE |
| K970589 | Microetcher ApKOJ · Traditional | Danville Engineering, Inc. | 09/17/1997SE |
| K964755 | Microjet Cavity Preparation SystemKOJ · Traditional | Midwest Dental Products Corp. | 09/11/1997SE |
| K970484 | Accu-PrepKOJ · Traditional | Bisco, Inc. | 07/01/1997SE |
| K970249 | Simplex AirbratorKOJ · Traditional | Simplex Medical Systems, Inc. | 05/07/1997SE |
| K964145 | Abradent Micro Abrasive Sandblaster Model DV-1KOJ · Traditional | Crystal Mark, Inc. | 12/31/1996SE |
| K964059 | MicadentKOJ · Traditional | Hampton Research | 12/19/1996SE |
| K955573 | Optiblast Intraoral SandblasterKOJ · Traditional | Buffalo Dental Mfg. Co., Inc. | 05/03/1996SE |
| K955050 | Jetstream Cavity Preparation SystemKOJ · Traditional | Dove Systems, Inc. | 03/07/1996SE |
| K931845 | SandblasterKOJ · Traditional | Mirage Dental Systems | 03/01/1995SE |
| K940776 | Kreativ Model KV-1KOJ · Traditional | Kreativ, Inc. | 12/21/1994SE |
| K932997 | Microprep Cavity Preperation SystemKOJ · Traditional | Sunrise Technologies, Inc. | 04/25/1994SE |
| K921748 | Model 2000 Dental Air Abrasive SystemKOJ · Traditional | Texas Airsonics, Inc. | 11/25/1992SE |
| K903284 | Young Prophy System, PS UnitKOJ · Traditional | Young Dental Manufacturing Co. 1, LLC | 12/17/1990SE |
| K902836 | MicroetcherKOJ · Traditional | Danville Engineering, Inc. | 11/20/1990SE |
| K875340 | Jetpolisher(Tm)KOJ · Traditional | Young Dental Manufacturing Co. 1, LLC | 06/10/1988SE |
| K871980 | D-23 Denture AdhesiveKOJ · Traditional | Solar Dental Co., Inc. | 06/05/1987SE |
| K862384 | Schein AP-1 Air Polishing UnitKOJ · Traditional | Henry Schein, Inc. | 11/07/1986SE |
| K852521 | Satlec Prophy Unit Pu 3055KOJ · Traditional | Spelna, Inc. | 07/31/1985SE |
| K840720 | Fiber Hemofilters FH55-FH77 & 88KOJ · Traditional | Gambro, Inc. | 04/24/1984SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0742-2012 | New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298…Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges… | Groman Inc. | 12/13/2010Terminated |