FDA Product Code
FDA Product Code EBF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3690
510(k) Clearances — 937 records · page 4 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K071278 | EMBRACE DUAL CURE COMPOSITE MATERIALS | Pulpdent Corporation | 2007-06-29 | Traditional | PDF ↗ |
| K071169 | CLEARFIL MAJESTY POSTERIOR PLT | Kuraray Medical, Inc. | 2007-06-20 | Traditional | PDF ↗ |
| K071386 | AMARIS/AMARIS FLOW | Voco GmbH | 2007-06-05 | Special | PDF ↗ |
| K070702 | FUSION RESIN CEMENT AND CORE KIT | Denali Corporation | 2007-05-10 | Traditional | PDF ↗ |
| K070693 | AURAVUE PIT & FISSURE SEALANT | Denali Corporation | 2007-05-09 | Traditional | PDF ↗ |
| K070583 | NANO COMPOSITE | Cosmedent, Inc. | 2007-04-16 | Traditional | PDF ↗ |
| K070325 | CLEARFIL MAJESTY ESTHETIC PLT | Kuraray Medical, Inc. | 2007-03-21 | Traditional | PDF ↗ |
| K070190 | GRADIA DIRECT X | GC America, Inc. | 2007-03-12 | Traditional | PDF ↗ |
| K070191 | ALPHA-CORE DC | Dental Technologies, Inc. | 2007-03-07 | Traditional | PDF ↗ |
| K063595 | CLEARFIL MAJESTY POSTERIOR | Kuraray America, Inc. | 2007-02-09 | Traditional | PDF ↗ |
| K063593 | CLEARFIL MAJESTY FLOW | Kuraray America, Inc. | 2007-02-02 | Traditional | PDF ↗ |
| K063714 | AXCEL FLOW | Tri Dental Innovators | 2007-01-31 | Traditional | PDF ↗ |
| K063604 | TWINKY STAR NF | Voco GmbH | 2007-01-22 | Abbreviated | PDF ↗ |
| K062345 | CERAMIC BOND | Voco GmbH | 2006-12-15 | Traditional | PDF ↗ |
| K062518 | CELERITY | Parkell, Inc. | 2006-12-04 | Traditional | PDF ↗ |
| K062515 | RETENTION FLOW OPAQUE | Heraeus Kulzer,GmbH | 2006-11-22 | Traditional | PDF ↗ |
| K062906 | ENA HFO COMPOSITE SYSTEM | Micerium S.P.A. | 2006-11-17 | Traditional | PDF ↗ |
| K062409 | K-ETCHANT GEL | Kuraray Medical, Inc. | 2006-11-08 | Traditional | PDF ↗ |
| K062343 | GRANDIO FLOW TRY-IN | Voco GmbH | 2006-11-02 | Traditional | PDF ↗ |
| K062157 | CONFORM | Apex Dental Materials, Inc. | 2006-10-13 | Traditional | PDF ↗ |
| K061906 | CLEARFIL CERAMIC PRIMER | Kuraray Medical, Inc. | 2006-09-28 | Traditional | PDF ↗ |
| K061860 | CLEARFIL MAJESTY ESTHETIC | Kuraray Medical, Inc. | 2006-09-18 | Traditional | PDF ↗ |
| K061664 | FORMCORE DC, MODEL 28-700100 | J. Morita USA, Inc. | 2006-09-08 | Traditional | PDF ↗ |
| K060893 | MODIFICATION TO REBILDA DC | Voco GmbH | 2006-05-25 | Special | PDF ↗ |
| K060472 | PREMISE FLOWABLE | Kerr Corporation | 2006-04-28 | Traditional | PDF ↗ |
| K060637 | DENFIL FLOW | Vericom Co., Ltd. | 2006-03-16 | Traditional | PDF ↗ |
| K051931 | AXCEL | Tri Dental Innovators | 2006-02-17 | Traditional | PDF ↗ |
| K053391 | X-TRA FIL | Voco GmbH | 2006-02-15 | Abbreviated | PDF ↗ |
| K052820 | PARAPOST PARACORE AUTOMIX 5ML | Coltene/Whaledent AG | 2006-01-09 | Traditional | PDF ↗ |
| K052779 | BRECOMP | Bredent-Products For the Dental Technician Laborat | 2005-12-20 | Traditional | PDF ↗ |
| K052106 | SIMILE FLOW | Pentron Clinical Technologies | 2005-10-31 | Traditional | PDF ↗ |
| K052097 | CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE | Dentsply International | 2005-08-12 | Special | PDF ↗ |
| K051808 | ESTELITE FLOW QUICK | Tokuyama Dental Corporation | 2005-08-08 | Traditional | PDF ↗ |
| K051818 | BEAUTIFIL FLOW | Shofu Dental Corp. | 2005-08-03 | Traditional | PDF ↗ |
| K051867 | GRANDIO | Voco GmbH | 2005-07-27 | Special | PDF ↗ |
| K051868 | GRANDIO FLOW | Voco GmbH | 2005-07-27 | Special | PDF ↗ |
| K050401 | CERAMAGE | Shofu Dental Corp. | 2005-04-28 | Traditional | PDF ↗ |
| K050880 | DYRACT EXTRA RESTORATIVE | Dentsply Intl. | 2005-04-22 | Special | PDF ↗ |
| K042804 | TESCERA OPAQUER POWDER/SCULPTING RESIN | Bisco, Inc. | 2005-02-01 | Traditional | PDF ↗ |
| K043119 | AMELOGEN PLUS | Ultradent Products, Inc. | 2004-12-17 | Special | PDF ↗ |
| K043177 | CLEAFIL DC CORE AUTOMIX | Kuraray Medical, Inc. | 2004-12-17 | Traditional | PDF ↗ |
| K042929 | ESTENIA C&B | Kuraray Medical Kurashiki Plant | 2004-12-06 | Traditional | PDF ↗ |
| K042348 | GRADIA DIRECT LOFLO | GC America, Inc. | 2004-11-18 | Traditional | PDF ↗ |
| K042819 | TETRIC EVOCERAM | Ivoclar Vivadent, Inc. | 2004-11-09 | Traditional | PDF ↗ |
| K042124 | DENFIL | Vericom Co., Ltd. | 2004-08-13 | Traditional | PDF ↗ |
| K040465 | LATIT FLOW | Ab Ardent | 2004-07-20 | Traditional | PDF ↗ |
| K040994 | COSMEDENT CORE PASTE | Cosmedent, Inc. | 2004-06-03 | Traditional | PDF ↗ |
| K040795 | MULTICORE HB; MULTICORE FLOW | Ivoclar Vivadent, Inc. | 2004-05-17 | Traditional | PDF ↗ |
| K040144 | QUIXX POSTERIOR RESTORATIVE | Dentsply International | 2004-04-01 | Traditional | PDF ↗ |
| K033970 | CLEARFIL PHOTO CORE PLT | Kuraray Medical, Inc. | 2004-03-26 | Traditional | PDF ↗ |
| K033996 | HERMES | 3M Espe AG Dental Products | 2004-02-24 | Traditional | PDF ↗ |
| K033808 | GRADIA GUM | GC America, Inc. | 2004-02-02 | Traditional | PDF ↗ |
| K033773 | CONCEPT HP ADD-ON; CONCEPT HP ENAMEL | Ivoclar Vivadent, AG | 2004-01-15 | Traditional | PDF ↗ |
| K033665 | VENUS FLOW | Heraeus Kulzer, Inc. | 2003-12-30 | Traditional | PDF ↗ |
| K033267 | EPRICORD | Kuraray Medical, Inc. | 2003-12-22 | Traditional | PDF ↗ |
| K033117 | GRANDIO FLOW | Voco GmbH | 2003-11-25 | Traditional | PDF ↗ |
| K032921 | PREMISE | Sybron Dental Specialties, Inc. | 2003-11-13 | Traditional | PDF ↗ |
| K031341 | STICK FLOW | Stick Tech , Ltd. | 2003-10-29 | Traditional | PDF ↗ |
| K031721 | COMPOSITE RESTORATION MATERIAL | Milton Hodosh, M.D. | 2003-09-11 | Traditional | PDF ↗ |
| K031877 | EMBRACE WET-BOND RESTORATIVE MATERIAL | Pulpdent Corporation | 2003-08-01 | Traditional | PDF ↗ |
| K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P | Bisco, Inc. | 2003-06-06 | Traditional | PDF ↗ |
| K030915 | GRANDIO | Voco GmbH | 2003-05-30 | Traditional | PDF ↗ |
| K030914 | REBILDA DC | Voco GmbH | 2003-05-30 | Traditional | PDF ↗ |
| K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE | Dentalez Group | 2003-04-29 | Traditional | PDF ↗ |
| K024094 | 4 SEASONS | Ivoclar Vivadent, Inc. | 2003-02-14 | Traditional | PDF ↗ |
| K023814 | GRADIA DIRECT | GC America, Inc. | 2003-01-30 | Traditional | PDF ↗ |
| K023742 | SCULPTURE PLUS NANO-HYBRID COMPOSITE | Pentron Laboratory Technologies | 2003-01-17 | Traditional | PDF ↗ |
| K022971 | MICROHYBRID 11 | Ab Ardent | 2002-11-25 | Traditional | PDF ↗ |
| K022974 | MICROHYBRID 12 | Ab Ardent | 2002-11-22 | Traditional | PDF ↗ |
| K022975 | ETCHING 15 | Ab Ardent | 2002-11-22 | Traditional | PDF ↗ |
| K022972 | MICROFILL 13 | Ab Ardent | 2002-11-22 | Traditional | PDF ↗ |
| K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | Prime Dental Manufacturing, Inc. | 2002-11-07 | Traditional | PDF ↗ |
| K023002 | CLEARFIL AP-X PLT | Kuraray Medical, Inc. | 2002-10-25 | Traditional | PDF ↗ |
| K022999 | CLEARFIL AP-X PLT INTRO KIT | Kuraray Medical, Inc. | 2002-10-24 | Traditional | PDF ↗ |
| K021250 | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) | Handpiece Unlimited | 2002-10-24 | Traditional | PDF ↗ |
| K022492 | PULPDENT SEMI-GEL ETCH | Pulpdent Corporation | 2002-10-11 | Traditional | PDF ↗ |
| K022797 | TWINKY STAR | Voco GmbH | 2002-10-10 | Abbreviated | PDF ↗ |
| K020113 | VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES | Vector Research & Development | 2002-05-17 | Traditional | PDF ↗ |
| K020760 | STARFLOW HV | Danville Materials, Inc. | 2002-05-03 | Traditional | PDF ↗ |
| K020555 | SONATA MICRO HYBRID COMPOSITE | Pentron Laboratory Technologies | 2002-04-22 | Traditional | PDF ↗ |
| K020432 | PULPDENT GLAZE | Pulpdent Corporation | 2002-04-17 | Traditional | PDF ↗ |
| K020342 | UNIFIL FLOW | GC America, Inc. | 2002-03-28 | Traditional | PDF ↗ |
| K014111 | REBILDA SC | Voco GmbH | 2002-03-06 | Traditional | PDF ↗ |
| K020131 | VENUS UNIVERSAL LIGHT CURING COMPOSITE | Heraeus Kulzer, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K013970 | PRIME-DENT HEMA DESENSITIZER | Prime Dental Manufacturing, Inc. | 2002-02-19 | Traditional | PDF ↗ |
| K014144 | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 | Afp Imaging Corp. | 2002-02-07 | Traditional | PDF ↗ |
| K013929 | HELIOMOLAR HB TRANSLUCENT SHADES | Ivoclar Vivadent, Inc. | 2002-02-07 | Traditional | PDF ↗ |
| K013510 | POINT 4 MODIFIED | Sybron Dental Specialties, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013571 | MAGICFIL | Dmg USA, Inc. | 2002-01-17 | Abbreviated | PDF ↗ |
| K011839 | DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C | Doxa Certex AB | 2002-01-17 | Traditional | PDF ↗ |
| K013647 | REVOLUTION FORMULA 2 | Sybron Dental Specialties, Inc. | 2002-01-16 | Traditional | PDF ↗ |
| K013529 | POINT 4 TRANSLUCENT MODIFIED | Sybron Dental Specialties, Inc. | 2002-01-09 | Traditional | PDF ↗ |
| K013400 | SYNERGY FLOW | Coltene/Whaledent, Inc. | 2001-12-10 | Traditional | PDF ↗ |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | Prime Dental Manufacturing, Inc. | 2001-11-05 | Traditional | PDF ↗ |
| K013375 | BELLEGLASS HP OPAQUE 2 | Kerr Dental Materials Center | 2001-10-29 | Traditional | PDF ↗ |
| K013325 | POINT 4 FLOWABLE 2 | Kerr Dental Materials Center | 2001-10-23 | Traditional | PDF ↗ |
| K012529 | ROK | Southern Dental Industries, Ltd. | 2001-10-22 | Traditional | PDF ↗ |
| K012528 | ICE | Southern Dental Industries, Ltd. | 2001-10-22 | Traditional | PDF ↗ |
| K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 | Sybron Dental Specialties, Inc. | 2001-10-03 | Traditional | PDF ↗ |
| K013007 | BELLEGLASS HP ENAMEL 2 | Sybron Dental Specialties, Inc. | 2001-10-01 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.