Material, Tooth Shade, Resin
Regulation 872.3690
18510(k)s in 12 months (937 all time)
2recalls in 12 months (71 all time)
71recalls that name a 510(k)
Top companies in EBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerr Corp. | 9 | 43 |
| Voco GmbH | 45 | 1 |
| Sybron Dental Specialties | 28 | 7 |
| Bisco, Inc. | 30 | 0 |
| Pulpdent Corp. | 29 | 0 |
| Scientific Pharmaceuticals, Inc. | 29 | 0 |
| Dentsply Intl. | 28 | 0 |
| Ivoclar North America, Inc. | 28 | 0 |
| Shofu Dental Corp. | 27 | 0 |
| GC America, Inc. | 24 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2007 | K071278 | EMBRACE DUAL CURE COMPOSITE MATERIALS Pulpdent Corporation | EBF |
| Jun 20, 2007 | K071169 | CLEARFIL MAJESTY POSTERIOR PLT Kuraray Medical, Inc. | EBF |
| Jun 5, 2007 | K071386 | AMARIS/AMARIS FLOW Voco GmbH, DE | EBF |
| May 10, 2007 | K070702 | FUSION RESIN CEMENT AND CORE KIT Denali Corporation | EBF |
| May 9, 2007 | K070693 | AURAVUE PIT & FISSURE SEALANT Denali Corporation | EBF |
| Apr 16, 2007 | K070583 | NANO COMPOSITE Cosmedent, Inc. | EBF |
| Mar 21, 2007 | K070325 | CLEARFIL MAJESTY ESTHETIC PLT Kuraray Medical, Inc. | EBF |
| Mar 12, 2007 | K070190 | GRADIA DIRECT X GC America, Inc. | EBF |
| Mar 7, 2007 | K070191 | ALPHA-CORE DC Dental Technologies, Inc. | EBF |
| Feb 9, 2007 | K063595 | CLEARFIL MAJESTY POSTERIOR Kuraray America, Inc. | EBF |
| Feb 2, 2007 | K063593 | CLEARFIL MAJESTY FLOW Kuraray America, Inc. | EBF |
| Jan 31, 2007 | K063714 | AXCEL FLOW Tri Dental Innovators | EBF |
| Jan 22, 2007 | K063604 | TWINKY STAR NF Voco GmbH, DE | EBF |
| Dec 15, 2006 | K062345 | CERAMIC BOND Voco GmbH, DE | EBF |
| Dec 4, 2006 | K062518 | CELERITY Parkell, Inc. | EBF |
| Nov 22, 2006 | K062515 | RETENTION FLOW OPAQUE Heraeus Kulzer,GmbH | EBF |
| Nov 17, 2006 | K062906 | ENA HFO COMPOSITE SYSTEM Micerium S.P.A., IT | EBF |
| Nov 8, 2006 | K062409 | K-ETCHANT GEL Kuraray Medical, Inc. | EBF |
| Nov 2, 2006 | K062343 | GRANDIO FLOW TRY-IN Voco GmbH, DE | EBF |
| Oct 13, 2006 | K062157 | CONFORM Apex Dental Materials, Inc. | EBF |
| Sep 28, 2006 | K061906 | CLEARFIL CERAMIC PRIMER Kuraray Medical, Inc. | EBF |
| Sep 18, 2006 | K061860 | CLEARFIL MAJESTY ESTHETIC Kuraray Medical, Inc. | EBF |
| Sep 8, 2006 | K061664 | FORMCORE DC, MODEL 28-700100 J. Morita USA, Inc. | EBF |
| May 25, 2006 | K060893 | MODIFICATION TO REBILDA DC Voco GmbH, DE | EBF |
| Apr 28, 2006 | K060472 | PREMISE FLOWABLE Kerr Corporation | EBF |
| Mar 16, 2006 | K060637 | DENFIL FLOW Vericom Co., Ltd., KR | EBF |
| Feb 17, 2006 | K051931 | AXCEL Tri Dental Innovators | EBF |
| Feb 15, 2006 | K053391 | X-TRA FIL Voco GmbH, DE | EBF |
| Jan 9, 2006 | K052820 | PARAPOST PARACORE AUTOMIX 5ML Coltene/Whaledent AG | EBF |
| Dec 20, 2005 | K052779 | BRECOMP Bredent-Products For the Dental Technician Laborat, DE | EBF |
| Oct 31, 2005 | K052106 | SIMILE FLOW Pentron Clinical Technologies | EBF |
| Aug 12, 2005 | K052097 | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE Dentsply International | EBF |
| Aug 8, 2005 | K051808 | ESTELITE FLOW QUICK Tokuyama Dental Corporation | EBF |
| Aug 3, 2005 | K051818 | BEAUTIFIL FLOW Shofu Dental Corp. | EBF |
| Jul 27, 2005 | K051868 | GRANDIO FLOW Voco GmbH | EBF |
| Jul 27, 2005 | K051867 | GRANDIO Voco GmbH | EBF |
| Apr 28, 2005 | K050401 | CERAMAGE Shofu Dental Corp. | EBF |
| Apr 22, 2005 | K050880 | DYRACT EXTRA RESTORATIVE Dentsply Intl. | EBF |
| Feb 1, 2005 | K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN Bisco, Inc. | EBF |
| Dec 17, 2004 | K043177 | CLEAFIL DC CORE AUTOMIX Kuraray Medical, Inc. | EBF |
| Dec 17, 2004 | K043119 | AMELOGEN PLUS Ultradent Products, Inc. | EBF |
| Dec 6, 2004 | K042929 | ESTENIA C&B Kuraray Medical Kurashiki Plant | EBF |
| Nov 18, 2004 | K042348 | GRADIA DIRECT LOFLO GC America, Inc. | EBF |
| Nov 9, 2004 | K042819 | TETRIC EVOCERAM Ivoclar Vivadent, Inc. | EBF |
| Aug 13, 2004 | K042124 | DENFIL Vericom Co., Ltd., KR | EBF |
| Jul 20, 2004 | K040465 | LATIT FLOW Ab Ardent | EBF |
| Jun 3, 2004 | K040994 | COSMEDENT CORE PASTE Cosmedent, Inc. | EBF |
| May 17, 2004 | K040795 | MULTICORE HB; MULTICORE FLOW Ivoclar Vivadent, Inc. | EBF |
| Apr 1, 2004 | K040144 | QUIXX POSTERIOR RESTORATIVE Dentsply International | EBF |
| Mar 26, 2004 | K033970 | CLEARFIL PHOTO CORE PLT Kuraray Medical, Inc. | EBF |
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