510(k) K071190

ROOT ZX II by J. Morita USA, Inc. — Product Code EKX

K071190 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "ROOT ZX II". The FDA issued a decision of Substantially Equivalent on August 17, 2007. 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.