510(k) K091065

AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4 by J. Morita USA, Inc. — Product Code EFB

K091065 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "AIR TORX, MODEL TRA-200, TRA-200-CP3, TRA-200-CP4". The FDA issued a decision of Substantially Equivalent on October 16, 2009. The device falls under product code EFB (Handpiece, Air-Powered, Dental), a Class I device regulated under 21 CFR 872.4200. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.