510(k) K142623

PANAVIA SA Cement Plus Handmix by Kuraray Noritake Dental, Inc. — Product Code EMA

K142623 is an FDA 510(k) premarket notification submitted by Kuraray Noritake Dental, Inc. for the device "PANAVIA SA Cement Plus Handmix". The FDA issued a decision of Substantially Equivalent on February 26, 2015. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Kuraray Noritake Dental, Inc. has at least 10 other 510(k) clearances on record.