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Kuraray America, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K111982CLEARFIL DC CORE PLUSNovember 17, 2011
K111980CLEARFIL TRI-S BOND PLUSOctober 14, 2011
K063595CLEARFIL MAJESTY POSTERIORFebruary 9, 2007
K063593CLEARFIL MAJESTY FLOWFebruary 2, 2007
K063228SURFACE COATDecember 8, 2006
K002322MODIFICATION TO PANAVIA FSeptember 18, 2000
K983361PANAVIA FNovember 13, 1998
K982259CHROMA ZONE COLOR STAINSeptember 22, 1998
K982164ESTENIAAugust 10, 1998
K974486CLEARFIL LINER BOND 2VJanuary 29, 1998
K974089ALLOY PRIMERDecember 17, 1997