510(k) K061271

ERCH ARCH BAR, MODEL 38-690-00 by KLS-Martin L.P. — Product Code DYX

K061271 is an FDA 510(k) premarket notification submitted by KLS-Martin L.P. for the device "ERCH ARCH BAR, MODEL 38-690-00". The FDA issued a decision of Substantially Equivalent on June 30, 2006. The device falls under product code DYX (Lock, Wire, And Ligature, Intraoral), a Class II device regulated under 21 CFR 872.4600. KLS-Martin L.P. has at least 10 other 510(k) clearances on record.