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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

CountryMakers
United States7
Switzerland2
Israel1
Germany1
United Kingdom1
Denmark1
China1
Italy1
Japan1

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.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Dell Dent Ltd.PETACH TIKVAH Central, IsraelManufacturer4February 19, 2002000api.fda.gov
Zest Anchors, LLCCarlsbad, CA, United StatesManufacturer, Repackager or relabeler, Specification developer3January 9, 2004000api.fda.gov
Crystalmark Dental Systems, Inc.Glendale, CA, United StatesManufacturer1December 31, 1996000api.fda.gov
Dentsply LLCYork, PA, United StatesSpecification developer1March 15, 2002000api.fda.gov
Groman Inc.Coconut Creek, FL, United StatesContract manufacturer, Manufacturer, Repackager or relabeler, Specification developer1April 15, 2003010api.fda.gov
Kavo Dental GMBHWARTHAUSEN Baden-Wurttemberg, GermanyManufacturer1November 23, 2004000api.fda.gov
Medivance Instruments Ltd.HARLESDEN, LONDON London, City of, United KingdomManufacturer1October 9, 2003000api.fda.gov
Parkell, Inc.Edgewood, NY, United StatesManufacturer1March 10, 1998000api.fda.gov
Ronvig Dental MFG. A/SDAUGAARD Midtjylland, DenmarkManufacturer1May 10, 2001000api.fda.gov
Dental Technologies, Inc.Lincolnwood, IL, United StatesContract manufacturer0000api.fda.gov
Danville Materials Research CenterAnaheim, CA, United StatesManufacturer0000api.fda.gov
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandComplaint file establishment, Specification developer0000api.fda.gov
E.M.S. Electro Medical Systems S.A.NYON Vaud, SwitzerlandManufacturer0000api.fda.gov
Guilin Woodpecker Medical Instrument Co., LtdGUILIN CITY Guangxi, ChinaManufacturer0000api.fda.gov
Mectron S.P.A.CARASCO Genova, ItalyManufacturer0000api.fda.gov
Nakanishi Inc.Kanuma Tochigi, JapanManufacturer0000api.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.