510(k) K112665

TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE by J. Morita USA, Inc. — Product Code EKX

K112665 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "TRI AUTO MINI - ENDODEONTIC TREATMENT MOTORIZED HANDPIECE". The FDA issued a decision of Substantially Equivalent on May 4, 2012. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.