Cleared Traditional

PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S

K120378 · Kuraray Medical, Inc. · Dental

Mar 2012

Decision

52d

Days

Class 2

Risk

About This 510(k) Submission

K120378 is an FDA 510(k) clearance for the PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S, a Cement, Dental (Class II — Special Controls, product code EMA), submitted by Kuraray Medical, Inc. (Chiyoda-Ku, JP). The FDA issued a Cleared decision on March 30, 2012, 52 days after receiving the submission on February 7, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K120378 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 07, 2012
Decision Date	March 30, 2012
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF