510(k) K022119

EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE by Electro Medical Systems SA — Product Code EFB

K022119 is an FDA 510(k) premarket notification submitted by Electro Medical Systems SA for the device "EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE". The FDA issued a decision of Substantially Equivalent on July 25, 2002. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. Electro Medical Systems SA has at least 10 other 510(k) clearances on record.