FDA 510(k) Applications Submitted by KURARAY MEDICAL INC.

FDA 510(k) Number Submission Date Device Name Applicant
K033938 12/19/2003 CLEARFIL PROTECT BOND KURARAY MEDICAL INC.
K100328 02/04/2010 CLEARFIL MAJETY POSTERIOR KURARAY MEDICAL INC.
K092281 07/29/2009 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC.
K070325 02/05/2007 CLEARFIL MAJESTY ESTHETIC PLT KURARAY MEDICAL INC.
K071169 04/27/2007 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC.
K081583 06/05/2008 CLEARFIL SA CEMENT KURARAY MEDICAL INC.
K061860 06/30/2006 CLEARFIL MAJESTY ESTHETIC KURARAY MEDICAL INC.
K061906 07/05/2006 CLEARFIL CERAMIC PRIMER KURARAY MEDICAL INC.
K062382 08/15/2006 CLEARFIL DC BOND KURARAY MEDICAL INC.
K062410 08/17/2006 CLEARFIL ESTHETIC CEMENT & DC BOND KURARAY MEDICAL INC.
K062409 08/17/2006 K-ETCHANT GEL KURARAY MEDICAL INC.
K021427 05/03/2002 CLEARFIL SA PRIMER KURARAY MEDICAL INC.
K012432 07/31/2001 MODIFICATION TO CLEARFIL PHOTO BOND KURARAY MEDICAL INC.
K012436 07/31/2001 MODIFICATION TO ALLOY PRIMER KURARAY MEDICAL INC.
K012438 07/31/2001 MODIFICATION TO PANAVIA 21 KURARAY MEDICAL INC.
K012440 07/31/2001 MODIFICATION TO CLEARFIL LINER BOND 2V KURARAY MEDICAL INC.
K012441 07/31/2001 PANAVIA F KURARAY MEDICAL INC.
K012442 07/31/2001 MODIFICATION TO CLEARFIL SE BOND KURARAY MEDICAL INC.
K012703 08/14/2001 CLEARFIL CORE NEW BOND KURARAY MEDICAL INC.
K012704 08/14/2001 CLEARFIL ST OPAQUER KURARAY MEDICAL INC.
K012705 08/14/2001 CLEARFIL PHOTO CORE KURARAY MEDICAL INC.
K012707 08/14/2001 ESTENIA KURARAY MEDICAL INC.
K012742 08/14/2001 TEETHMATE F-1 KURARAY MEDICAL INC.
K012740 08/14/2001 CLEARFIL AP-X KURARAY MEDICAL INC.
K012737 08/14/2001 CHROMA ZONE COLOR STAIN KURARAY MEDICAL INC.
K012735 08/14/2001 CLEARFIL DC CEMENT KURARAY MEDICAL INC.
K012734 08/14/2001 CLEARFIL NEW BOND KURARAY MEDICAL INC.
K012733 08/14/2001 CARIES DETECTOR KURARAY MEDICAL INC.
K012730 08/14/2001 CLEARFIL PORCELAIN BOND ACTIVATOR KURARAY MEDICAL INC.
K012729 08/14/2001 CLEARFIL REPAIR KURARAY MEDICAL INC.
K023002 09/09/2002 CLEARFIL AP-X PLT KURARAY MEDICAL INC.
K022999 09/09/2002 CLEARFIL AP-X PLT INTRO KIT KURARAY MEDICAL INC.
K023842 11/18/2002 CLEARFIL SE BOND PLUS KURARAY MEDICAL INC.
K024356 12/30/2002 CLEARFIL SILANE KIT KURARAY MEDICAL INC.
K120378 02/07/2012 PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC.
K120379 02/07/2012 PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC.
K111975 07/12/2011 CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK KURARAY MEDICAL INC.
K032455 08/11/2003 PANAVIA F 2.0 KURARAY MEDICAL INC.
K033267 10/09/2003 EPRICORD KURARAY MEDICAL INC.
K042913 10/21/2004 CLEARFIL TRI-S BOND KURARAY MEDICAL INC.
K043177 11/16/2004 CLEAFIL DC CORE AUTOMIX KURARAY MEDICAL INC.
K033970 12/22/2003 CLEARFIL PHOTO CORE PLT KURARAY MEDICAL INC.


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