510(k) K161042

CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack by Kuraray Noritake Dental, Inc. — Product Code KLE

K161042 is an FDA 510(k) premarket notification submitted by Kuraray Noritake Dental, Inc. for the device "CLEARFIL Universal Bond Quick Bottle Standard Kit, CLEARFIL Universal Bond Quick Bottle Refill, CLEARFIL Universal Bond Quick Bottle Value pack". The FDA issued a decision of Substantially Equivalent on October 25, 2016. The device falls under product code KLE (Agent, Tooth Bonding, Resin), a Class II device regulated under 21 CFR 872.3200. Kuraray Noritake Dental, Inc. has at least 10 other 510(k) clearances on record.