510(k) K871635

CLEARFIL POSTERIOR 3 by Kuraray Co. — Product Code EBF

K871635 is an FDA 510(k) premarket notification submitted by Kuraray Co. for the device "CLEARFIL POSTERIOR 3". The FDA issued a decision of Substantially Equivalent on July 16, 1987. The device falls under product code EBF (Material, Tooth Shade, Resin), a Class II device regulated under 21 CFR 872.3690. Kuraray Co. has at least 10 other 510(k) clearances on record.