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EBF

934 FDA 510(k) clearances · Product code

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RecordFirmDate
FUSION RESIN CEMENT AND CORE KIT (K070702)Denali Corporation2007-05-10
AURAVUE PIT & FISSURE SEALANT (K070693)Denali Corporation2007-05-09
NANO COMPOSITE (K070583)Cosmedent, Inc.2007-04-16
CLEARFIL MAJESTY ESTHETIC PLT (K070325)Kuraray Medical, Inc.2007-03-21
GRADIA DIRECT X (K070190)GC America, Inc.2007-03-12
ALPHA-CORE DC (K070191)Dental Technologies, Inc.2007-03-07
CLEARFIL MAJESTY POSTERIOR (K063595)Kuraray America, Inc.2007-02-09
CLEARFIL MAJESTY FLOW (K063593)Kuraray America, Inc.2007-02-02
AXCEL FLOW (K063714)Tri Dental Innovators2007-01-31
TWINKY STAR NF (K063604)Voco GmbH2007-01-22
CERAMIC BOND (K062345)Voco GmbH2006-12-15
CELERITY (K062518)Parkell, Inc.2006-12-04
RETENTION FLOW OPAQUE (K062515)Heraeus Kulzer,GmbH2006-11-22
ENA HFO COMPOSITE SYSTEM (K062906)Micerium S.P.A.2006-11-17
K-ETCHANT GEL (K062409)Kuraray Medical, Inc.2006-11-08
GRANDIO FLOW TRY-IN (K062343)Voco GmbH2006-11-02
CONFORM (K062157)Apex Dental Materials, Inc.2006-10-13
CLEARFIL CERAMIC PRIMER (K061906)Kuraray Medical, Inc.2006-09-28
CLEARFIL MAJESTY ESTHETIC (K061860)Kuraray Medical, Inc.2006-09-18
FORMCORE DC, MODEL 28-700100 (K061664)J. Morita USA, Inc.2006-09-08
MODIFICATION TO REBILDA DC (K060893)Voco GmbH2006-05-25
PREMISE FLOWABLE (K060472)Kerr Corporation2006-04-28
DENFIL FLOW (K060637)Vericom Co., Ltd.2006-03-16
AXCEL (K051931)Tri Dental Innovators2006-02-17
X-TRA FIL (K053391)Voco GmbH2006-02-15
PARAPOST PARACORE AUTOMIX 5ML (K052820)Coltene/Whaledent AG2006-01-09
BRECOMP (K052779)Bredent-Products For the Dental Technician Laborat2005-12-20
SIMILE FLOW (K052106)Pentron Clinical Technologies2005-10-31
CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE (K052097)Dentsply International2005-08-12
ESTELITE FLOW QUICK (K051808)Tokuyama Dental Corporation2005-08-08
BEAUTIFIL FLOW (K051818)Shofu Dental Corp.2005-08-03
GRANDIO FLOW (K051868)Voco GmbH2005-07-27
GRANDIO (K051867)Voco GmbH2005-07-27
CERAMAGE (K050401)Shofu Dental Corp.2005-04-28
DYRACT EXTRA RESTORATIVE (K050880)Dentsply Intl.2005-04-22
TESCERA OPAQUER POWDER/SCULPTING RESIN (K042804)Bisco, Inc.2005-02-01
CLEAFIL DC CORE AUTOMIX (K043177)Kuraray Medical, Inc.2004-12-17
AMELOGEN PLUS (K043119)Ultradent Products, Inc.2004-12-17
ESTENIA C&B (K042929)Kuraray Medical Kurashiki Plant2004-12-06
GRADIA DIRECT LOFLO (K042348)GC America, Inc.2004-11-18
TETRIC EVOCERAM (K042819)Ivoclar Vivadent, Inc.2004-11-09
DENFIL (K042124)Vericom Co., Ltd.2004-08-13
LATIT FLOW (K040465)Ab Ardent2004-07-20
COSMEDENT CORE PASTE (K040994)Cosmedent, Inc.2004-06-03
MULTICORE HB; MULTICORE FLOW (K040795)Ivoclar Vivadent, Inc.2004-05-17
QUIXX POSTERIOR RESTORATIVE (K040144)Dentsply International2004-04-01
CLEARFIL PHOTO CORE PLT (K033970)Kuraray Medical, Inc.2004-03-26
HERMES (K033996)3M Espe AG Dental Products2004-02-24
GRADIA GUM (K033808)GC America, Inc.2004-02-02
CONCEPT HP ADD-ON; CONCEPT HP ENAMEL (K033773)Ivoclar Vivadent, AG2004-01-15
VENUS FLOW (K033665)Heraeus Kulzer, Inc.2003-12-30
EPRICORD (K033267)Kuraray Medical, Inc.2003-12-22
GRANDIO FLOW (K033117)Voco GmbH2003-11-25
PREMISE (K032921)Sybron Dental Specialties, Inc.2003-11-13
STICK FLOW (K031341)Stick Tech , Ltd.2003-10-29
COMPOSITE RESTORATION MATERIAL (K031721)Milton Hodosh, M.D.2003-09-11
EMBRACE WET-BOND RESTORATIVE MATERIAL (K031877)Pulpdent Corporation2003-08-01
TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P (K030951)Bisco, Inc.2003-06-06
GRANDIO (K030915)Voco GmbH2003-05-30
REBILDA DC (K030914)Voco GmbH2003-05-30
SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE (K030133)Dentalez Group2003-04-29
4 SEASONS (K024094)Ivoclar Vivadent, Inc.2003-02-14
GRADIA DIRECT (K023814)GC America, Inc.2003-01-30
SCULPTURE PLUS NANO-HYBRID COMPOSITE (K023742)Pentron Laboratory Technologies2003-01-17
MICROHYBRID 11 (K022971)Ab Ardent2002-11-25
MICROHYBRID 12 (K022974)Ab Ardent2002-11-22
ETCHING 15 (K022975)Ab Ardent2002-11-22
MICROFILL 13 (K022972)Ab Ardent2002-11-22
PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL (K022675)Prime Dental Manufacturing, Inc.2002-11-07
CLEARFIL AP-X PLT (K023002)Kuraray Medical, Inc.2002-10-25
CLEARFIL AP-X PLT INTRO KIT (K022999)Kuraray Medical, Inc.2002-10-24
MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) (K021250)Handpiece Unlimited2002-10-24
PULPDENT SEMI-GEL ETCH (K022492)Pulpdent Corporation2002-10-11
TWINKY STAR (K022797)Voco GmbH2002-10-10
VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES (K020113)Vector Research & Development2002-05-17
STARFLOW HV (K020760)Danville Materials, Inc.2002-05-03
SONATA MICRO HYBRID COMPOSITE (K020555)Pentron Laboratory Technologies2002-04-22
PULPDENT GLAZE (K020432)Pulpdent Corporation2002-04-17
UNIFIL FLOW (K020342)GC America, Inc.2002-03-28
REBILDA SC (K014111)Voco GmbH2002-03-06
VENUS UNIVERSAL LIGHT CURING COMPOSITE (K020131)Heraeus Kulzer, Inc.2002-02-28
PRIME-DENT HEMA DESENSITIZER (K013970)Prime Dental Manufacturing, Inc.2002-02-19
EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 (K014144)Afp Imaging Corp.2002-02-07
HELIOMOLAR HB TRANSLUCENT SHADES (K013929)Ivoclar Vivadent, Inc.2002-02-07
POINT 4 MODIFIED (K013510)Sybron Dental Specialties, Inc.2002-01-18
MAGICFIL (K013571)Dmg USA, Inc.2002-01-17
DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C (K011839)Doxa Certex AB2002-01-17
REVOLUTION FORMULA 2 (K013647)Sybron Dental Specialties, Inc.2002-01-16
POINT 4 TRANSLUCENT MODIFIED (K013529)Sybron Dental Specialties, Inc.2002-01-09
SYNERGY FLOW (K013400)Coltene/Whaledent, Inc.2001-12-10
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT (K012794)Prime Dental Manufacturing, Inc.2001-11-05
BELLEGLASS HP OPAQUE 2 (K013375)Kerr Dental Materials Center2001-10-29
POINT 4 FLOWABLE 2 (K013325)Kerr Dental Materials Center2001-10-23
ICE (K012528)Southern Dental Industries, Ltd.2001-10-22
ROK (K012529)Southern Dental Industries, Ltd.2001-10-22
BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 (K013009)Sybron Dental Specialties, Inc.2001-10-03
BELLEGLASS HP ENAMEL 2 (K013007)Sybron Dental Specialties, Inc.2001-10-01
COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 (K012160)Premier Dental Products Co.2001-09-27
CHROMA ZONE COLOR STAIN (K012737)Kuraray Medical, Inc.2001-09-14
CLEARFIL AP-X (K012740)Kuraray Medical, Inc.2001-09-14
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