KOJClass II

Airbrush

Dental · 21 CFR 872.6080

MDR events19All time

Recalls1All time

Registered firms33Currently listed

510(k) clearances48All time

Recent MDR events

19 adverse event reports on file

Event type breakdown

Injury18

Malfunction1

Most-reported manufacturers

Dentsply Professional9 Hu-friedy Mfg. Co. Llc2 American Dental Airsonic Tech1 Danville Materials1 Dentist Preferred Inc.1 Dentsply Detrey1 Kaltenbach & Voigt Gmbh1 Kavo Dental1

Recalls

1 recall events for this product code

Groman Inc.
TerminatedJan 13, 2012
New Label: EtchMaster ***Cordless Handpiece***P/N 797 www.GromanDental.com 1800-906-9298 HAZARD WARNING: Using CO2 cartridges from other suppliers may cause an
Groman Inc. of Margate, FL recalled their product Cordless Etcher Air Brush. When non-conforming cartridges are inserted into the Cordless Etcher they can induce excessive stresses on the device causing cracks in the plastic housing of the device. These crack can lead to a hazardous situation due to the high pressure of the gas contained in the CO2 cartridges.
Z-0742-2012 · View FDA record ↗

Registered firms

33 firms currently registered for this product code

510(k) clearances

48 clearances for this product code