ClearanceBrief
Panels › Dental › Product code EBF · Class 2

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)
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Top companies in EBF

Company510(k)sRecalls
Kerr Corp.943
Voco GmbH451
Sybron Dental Specialties287
Bisco, Inc.300
Pulpdent Corp.290
Scientific Pharmaceuticals, Inc.290
Dentsply Intl.280
Ivoclar North America, Inc.280
Shofu Dental Corp.270
GC America, Inc.240
Decided510(k)Device and applicantCode
Oct 3, 2013K132141BEAUTIFIL BULK FLOWABLE
Shofu Dental Corporation
EBF
Sep 11, 2013K130841SHOFU BLOCK HC
Shofu Dental Corporation
EBF
Aug 13, 2013K130672OPTIFLOW II FLOWABLE COMPOSITE, LC
Pac-Dent International, Inc.
EBF
Jul 23, 2013K123631MFP-051
GC America, Inc.
EBF
Jul 16, 2013K131504UNIVERSAL OPAQUE
Shofu Dental Corporation
EBF
May 31, 2013K123823INTERLIG
Angelus Industria DE Productos Odontologicos
EBF
Apr 9, 2013K130371CLEARFIL MAJESTY ES FLOW
Kuraray Noritake Dental, Inc., JP
EBF
Mar 5, 2013K121769DENTOCORE / DENTOCORE BODY
Itena Clinical, CA
EBF
Feb 21, 2013K121735FIBER DISK AND BLOCK PERMANENT, TRINIA
Bioloren S.R.L., IT
EBF
Jan 31, 2013K123397MULTILINK AUTOMIX
Ivoclar Vivadent, AG, LI
EBF
Jan 24, 2013K123304SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO
Ivoclar Vivadent, AG
EBF
Dec 21, 2012K123773X-TRA BASE
Voco GmbH, DE
EBF
Dec 11, 2012K120237BPA-FREE MICROHYBID COMPOSITE
Novocol, Inc.
EBF
Sep 28, 2012K121915BRIGHT RESTORATIVE MATERIALS
Dmp, Ltd., GR
EBF
Sep 25, 2012K121880DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID
Danville Materials, Inc.
EBF
Sep 12, 2012K122569LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR
3M Company
EBF
Aug 29, 2012K121230IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE
Ivoclar Vivadent, AG, LI
EBF
Jul 25, 2012K121583CLEARFIL MAJESTY FLOW
Kuraray Noritake Dental, Inc.
EBF
May 3, 2012K120768ES FLOW
Spident Co., Ltd., KR
EBF
Mar 19, 2012K120453FILTEK BULK FILL FLOWABLE RESTORATIVE
3M Espe Dental Products
EBF
Mar 2, 2012K113617SPEE-DEE PATCH
Pulpdent Corporation
EBF
Jan 26, 2012K112044ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A
Anaxdent GmbH
EBF
Dec 21, 2011K113563N-HYBRIDE-COMPOSITE LC
Voco GmbH, DE
EBF
Dec 21, 2011K113444N-HYBRIDE-COMPOSITE LC FLOW
Voco GmbH, DE
EBF
Dec 14, 2011K112501VENUS PEARL PLT REFILL A1
Heraeus Kulzer, LLC
EBF
Nov 21, 2011K112168COMPONEER
Coltene/Whaledent AG
EBF
Nov 17, 2011K111982CLEARFIL DC CORE PLUS
Kuraray America, Inc.
EBF
Nov 8, 2011K112447GRANDIO CORE DUAL CURE
Voco GmbH, DE
EBF
Oct 20, 2011K112374X-TRA BASE
Voco GmbH, DE
EBF
Oct 14, 2011K111958TETRIC EVOCERAM BULK FILL
Ivoclar Vivadent, Inc.
EBF
Jun 23, 2011K110859METAL OPAQUER
Apex Dental Materials, Inc.
EBF
May 27, 2011K110642SILJETR SYSTEM
Danville Materials, Inc.
EBF
May 27, 2011K110589CIMARA
Voco GmbH, DE
EBF
Apr 5, 2011K110178ESTELITE COLOR
Tokuyama Dental Corporation
EBF
Feb 25, 2011K110428ESCOM 100
Spident Co., Ltd., KR
EBF
Feb 25, 2011K103528IPS EMPRESS DIRECT FLOW
Ivoclar Vivadent, Inc.
EBF
Feb 2, 2011K103190PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
Silmet , Ltd., IL
EBF
Jan 21, 2011K110131LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE
3M Espe Dental Products
EBF
Jan 21, 2011K103580GRANDIO SO FLOW
Voco GmbH, DE
EBF
Jan 20, 2011K103351DMC COMPOSITE 2
Kerr Corporation
EBF
Jan 5, 2011K102703BUILD-IT TOTAL CORE
Pentron Clinical
EBF
Dec 8, 2010K102984AURA
Sdi Limited, AU
EBF
Nov 23, 2010K102255DMP ETCHING GEL
Dmp, Ltd., GR
EBF
Nov 19, 2010K102257NANOCERAM- BRIGHT
Dmp, Ltd., GR
EBF
Nov 17, 2010K102603SA FLOWABLE ADHESIVE
Dmg USA, Inc.
EBF
Nov 8, 2010K102354GRANDIO SO HEAVY FLOW
Voco GmbH, DE
EBF
Nov 2, 2010K102351GRANDIO SO
Voco GmbH, DE
EBF
Oct 29, 2010K101540GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE
Novocol Inc. Dba Septodont and Confi-Dental Produc
EBF
Oct 22, 2010K102526BLO2X OXYGEN BLOCKER
Pascal Co., Inc.
EBF
Oct 8, 2010K102450IONOLUX PRO
Voco GmbH, DE
EBF

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