Company ยท US
Kuraray Medical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2012. Name variants (Inc, Corp, punctuation) are merged.
42510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2012 | K120379 | PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S Kuraray Medical, Inc., JP | EMA |
| Mar 30, 2012 | K120378 | PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S Kuraray Medical, Inc., JP | EMA |
| Oct 14, 2011 | K111975 | CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK Kuraray Medical, Inc., JP | KLE |
| Mar 5, 2010 | K100328 | CLEARFIL MAJETY POSTERIOR Kuraray Medical, Inc. | EBF |
| Oct 27, 2009 | K092281 | CLEARFIL MAJESTY POSTERIOR PLT Kuraray Medical, Inc. | EBF |
| Jul 28, 2008 | K081583 | CLEARFIL SA CEMENT Kuraray Medical, Inc. | EMA |
| Jun 20, 2007 | K071169 | CLEARFIL MAJESTY POSTERIOR PLT Kuraray Medical, Inc. | EBF |
| Mar 21, 2007 | K070325 | CLEARFIL MAJESTY ESTHETIC PLT Kuraray Medical, Inc. | EBF |
| Nov 8, 2006 | K062409 | K-ETCHANT GEL Kuraray Medical, Inc. | EBF |
| Sep 28, 2006 | K061906 | CLEARFIL CERAMIC PRIMER Kuraray Medical, Inc. | EBF |
| Sep 27, 2006 | K062382 | CLEARFIL DC BOND Kuraray Medical, Inc. | KLE |
| Sep 26, 2006 | K062410 | CLEARFIL ESTHETIC CEMENT & DC BOND Kuraray Medical, Inc. | EMA |
| Sep 18, 2006 | K061860 | CLEARFIL MAJESTY ESTHETIC Kuraray Medical, Inc. | EBF |
| Dec 17, 2004 | K043177 | CLEAFIL DC CORE AUTOMIX Kuraray Medical, Inc. | EBF |
| Nov 26, 2004 | K042913 | CLEARFIL TRI-S BOND Kuraray Medical, Inc. | KLE |
| Mar 26, 2004 | K033970 | CLEARFIL PHOTO CORE PLT Kuraray Medical, Inc. | EBF |
| Jan 29, 2004 | K033938 | CLEARFIL PROTECT BOND Kuraray Medical, Inc. | KLE |
| Dec 22, 2003 | K033267 | EPRICORD Kuraray Medical, Inc. | EBF |
| Nov 7, 2003 | K032455 | PANAVIA F 2.0 Kuraray Medical, Inc. | EMA |
| Mar 26, 2003 | K024356 | CLEARFIL SILANE KIT Kuraray Medical, Inc. | KLE |
| Feb 11, 2003 | K023842 | CLEARFIL SE BOND PLUS Kuraray Medical, Inc. | KLE |
| Oct 25, 2002 | K023002 | CLEARFIL AP-X PLT Kuraray Medical, Inc. | EBF |
| Oct 24, 2002 | K022999 | CLEARFIL AP-X PLT INTRO KIT Kuraray Medical, Inc. | EBF |
| Jun 7, 2002 | K021427 | CLEARFIL SA PRIMER Kuraray Medical, Inc. | KLE |
| Sep 14, 2001 | K012742 | TEETHMATE F-1 Kuraray Medical, Inc. | EBC |
| Sep 14, 2001 | K012740 | CLEARFIL AP-X Kuraray Medical, Inc. | EBF |
| Sep 14, 2001 | K012737 | CHROMA ZONE COLOR STAIN Kuraray Medical, Inc. | EBF |
| Sep 14, 2001 | K012735 | CLEARFIL DC CEMENT Kuraray Medical, Inc. | EMA |
| Sep 14, 2001 | K012734 | CLEARFIL NEW BOND Kuraray Medical, Inc. | KLE |
| Sep 14, 2001 | K012733 | CARIES DETECTOR Kuraray Medical, Inc. | LFC |
| Sep 13, 2001 | K012730 | CLEARFIL PORCELAIN BOND ACTIVATOR Kuraray Medical, Inc. | KLE |
| Sep 13, 2001 | K012729 | CLEARFIL REPAIR Kuraray Medical, Inc. | KLE |
| Sep 13, 2001 | K012707 | ESTENIA Kuraray Medical, Inc. | EBF |
| Sep 11, 2001 | K012705 | CLEARFIL PHOTO CORE Kuraray Medical, Inc. | EBF |
| Sep 10, 2001 | K012704 | CLEARFIL ST OPAQUER Kuraray Medical, Inc. | EBF |
| Sep 10, 2001 | K012703 | CLEARFIL CORE NEW BOND Kuraray Medical, Inc. | EBF |
| Sep 10, 2001 | K012442 | MODIFICATION TO CLEARFIL SE BOND Kuraray Medical, Inc. | KLE |
| Sep 6, 2001 | K012441 | PANAVIA F Kuraray Medical, Inc. | EMA |
| Sep 5, 2001 | K012440 | MODIFICATION TO CLEARFIL LINER BOND 2V Kuraray Medical, Inc. | KLE |
| Sep 5, 2001 | K012438 | MODIFICATION TO PANAVIA 21 Kuraray Medical, Inc. | EMA |
| Sep 4, 2001 | K012436 | MODIFICATION TO ALLOY PRIMER Kuraray Medical, Inc. | KLE |
| Sep 4, 2001 | K012432 | MODIFICATION TO CLEARFIL PHOTO BOND Kuraray Medical, Inc. | KLE |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||