510(k) K070074

LUBRINA, MODEL HIM-1 by J. Morita USA, Inc. — Product Code EFB

K070074 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "LUBRINA, MODEL HIM-1". The FDA issued a decision of Substantially Equivalent on May 31, 2007. 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.