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
Aug 23, 2010K101621LITE ART
Shofu Dental Corp.
EBF
Aug 23, 2010K101603BEAUTIFIL FLOW PLUS
Shofu Dental Corp.
EBF
Aug 19, 2010K101213GRANDIO FLOW
Voco GmbH, DE
EBF
May 12, 2010K101215NUANCE
Discus Dental, LLC
EBF
May 12, 2010K100235FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE
3M Company
EBF
Mar 19, 2010K100083ESTHETICA
Kerr Corporation
EBF
Mar 5, 2010K100328CLEARFIL MAJETY POSTERIOR
Kuraray Medical, Inc.
EBF
Mar 3, 2010K100413TEMP IT
Spident Co., Ltd., KR
EBF
Feb 17, 2010K093470CORE-FLO D/C
Bisco, Inc.
EBF
Jan 27, 2010K093484PREMISE FLOWABLE MODIFIED
Kerr Corporation
EBF
Dec 16, 2009K092912STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150
Danville Materials, Inc.
EBF
Nov 20, 2009K092730COSMEDENT BRUSHABLE COMPOSITE
Cosmedent, Inc.
EBF
Nov 12, 2009K092501LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
Novocol, Inc.
EBF
Oct 30, 2009K091512BUILD-IT LIGHT CURE
Pentron Clinical Technologies
EBF
Oct 27, 2009K092281CLEARFIL MAJESTY POSTERIOR PLT
Kuraray Medical, Inc.
EBF
Oct 14, 2009K091091SONICFILL 2010
Sybron Dental Specialties, Inc.
EBF
Oct 1, 2009K092539SEAMFREE
Apex Dental Materials, Inc.
EBF
Sep 21, 2009K091647INJECTAFIL
Apex Dental Materials, Inc.
EBF
Sep 3, 2009K091635VENUS DIAMOND FLOW
Heraeus Kulzer, LLC
EBF
Aug 26, 2009K092572CORE*IT DUAL
Spident Co., Ltd., KR
EBF
Jul 22, 2009K091388GCUC-505
GC America, Inc.
EBF
Jun 17, 2009K090843AMARIS GINGIVA OPAQUER
Voco GmbH, DE
EBF
Jun 17, 2009K090704MULTILINK IMPLANT
Ivoclar Vivadent, Inc.
EBF
Jun 10, 2009K090747MI FLOW (GCUC-450)
GC America, Inc.
EBF
May 21, 2009K091023METAMORPHOSIS
Kerr Corporation
EBF
May 11, 2009K090391PULPDENT MICRO-HYBRID COMPOSITE
Pulpdent Corporation
EBF
Apr 29, 2009K090701EMPRESS DIRECT
Ivoclar Vivadent, Inc.
EBF
Apr 14, 2009K083841ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL
Dentsply International, Inc.
EBF
Apr 3, 2009K090292PREMISE MODIFIED
Kerr Corp.
EBF
Feb 10, 2009K083326FLUOROCORE 2
Dentsply International, Inc.
EBF
Dec 17, 2008K083610FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE
3M Company
EBF
Dec 11, 2008K082671HERCULITE ULTRA
Sybron Dental Specialties
EBF
Nov 14, 2008K082434GDLS-200
GC America, Inc.
EBF
Oct 30, 2008K082171GRADIA CORE
GC America, Inc.
EBF
Aug 12, 2008K081695DMC COMPOSITE
Kerr Corp.
EBF
Aug 7, 2008K073047APROXI 1100 AND 4000 SERIES DENTAL INLAYS
Aproxi Aps, DK
EBF
Jun 19, 2008K080940ESTELITE SIGMA QUICK
Tokuyama Dental Corporation
EBF
Jun 5, 2008K080478GRADIA FORTE
GC America, Inc.
EBF
May 30, 2008K080480NANOCOMPOSITE RESTORATIVE KIT
Dmg USA, Inc.
EBF
Apr 7, 2008K080305NEXCOMP AND META ETCHANT
Meta Biomed Co., Ltd., KR
EBF
Feb 28, 2008K080068BEAUTIFIL OPAQUER
Shofu Dental Corp.
EBF
Feb 15, 2008K0727333M ESPE ADULT CROWN
3M Company
EBF
Feb 6, 2008K080265DENFIL ETCHANT-37
Vericom Co., Ltd., KR
EBF
Feb 4, 2008K073554NEUN
Heraeus Kulzer,GmbH
EBF
Dec 4, 2007K072746E-1 ESTHETIC COMPOSITE SYSTEM
Tokuyama Dental Corporation
EBF
Oct 26, 2007K072545ARTISTE SE FLOWABLE COMPOSITE, MODEL N280
Pentron Clinical Technologies
EBF
Sep 28, 2007K072069SPACER
Vericom Co., Ltd.
EBF
Sep 13, 2007K072150DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL
Novocol, Inc.
EBF
Aug 15, 2007K071742BEAUTIFIL II
Shofu Dental Corp.
EBF
Jul 19, 2007K071288MODIFICATION TO KAVO QUATTROCARE
Sybron Dental Specialties, Inc.
EBF

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