510(k) K100328

CLEARFIL MAJETY POSTERIOR by Kuraray Medical, Inc. — Product Code EBF

K100328 is an FDA 510(k) premarket notification submitted by Kuraray Medical, Inc. for the device "CLEARFIL MAJETY POSTERIOR". The FDA issued a decision of Substantially Equivalent on March 5, 2010. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Kuraray Medical, Inc. has at least 10 other 510(k) clearances on record.