510(k) K120379

PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S by Kuraray Medical, Inc. — Product Code EMA

K120379 is an FDA 510(k) premarket notification submitted by Kuraray Medical, Inc. for the device "PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S". The FDA issued a decision of Substantially Equivalent on March 30, 2012. The device falls under product code EMA (Cement, Dental), a Class II device regulated under 21 CFR 872.3275. Kuraray Medical, Inc. has at least 10 other 510(k) clearances on record.