Data / Medical devices / Airbrush
Airbrush (KOJ): 16 FDA-registered makers in 9 countries
16 establishments in 9 countries are registered with the FDA to make Airbrush (product code KOJ, Class 2, 21 CFR 872.6080). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 48 510(k) clearances under this code, the latest on May 9, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KOJ
- Device class
- 2
- Regulation
- 872.6080
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Switzerland | 2 |
| Israel | 1 |
| Germany | 1 |
| United Kingdom | 1 |
| Denmark | 1 |
| China | 1 |
| Italy | 1 |
| Japan | 1 |
Makers of Airbrush
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Dell Dent Ltd. | PETACH TIKVAH Central, Israel | Manufacturer | 4 | February 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Zest Anchors, LLC | Carlsbad, CA, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | January 9, 2004 | 0 | 0 | 0 | api.fda.gov |
| Crystalmark Dental Systems, Inc. | Glendale, CA, United States | Manufacturer | 1 | December 31, 1996 | 0 | 0 | 0 | api.fda.gov |
| Dentsply LLC | York, PA, United States | Specification developer | 1 | March 15, 2002 | 0 | 0 | 0 | api.fda.gov |
| Groman Inc. | Coconut Creek, FL, United States | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | 1 | April 15, 2003 | 0 | 1 | 0 | api.fda.gov |
| Kavo Dental GMBH | WARTHAUSEN Baden-Wurttemberg, Germany | Manufacturer | 1 | November 23, 2004 | 0 | 0 | 0 | api.fda.gov |
| Medivance Instruments Ltd. | HARLESDEN, LONDON London, City of, United Kingdom | Manufacturer | 1 | October 9, 2003 | 0 | 0 | 0 | api.fda.gov |
| Parkell, Inc. | Edgewood, NY, United States | Manufacturer | 1 | March 10, 1998 | 0 | 0 | 0 | api.fda.gov |
| Ronvig Dental MFG. A/S | DAUGAARD Midtjylland, Denmark | Manufacturer | 1 | May 10, 2001 | 0 | 0 | 0 | api.fda.gov |
| Dental Technologies, Inc. | Lincolnwood, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Danville Materials Research Center | Anaheim, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E.M.S. Electro Medical Systems S.A. | NYON Vaud, Switzerland | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| E.M.S. Electro Medical Systems S.A. | NYON Vaud, Switzerland | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guilin Woodpecker Medical Instrument Co., Ltd | GUILIN CITY Guangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mectron S.P.A. | CARASCO Genova, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Nakanishi Inc. | Kanuma Tochigi, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.