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 3 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K132141 | BEAUTIFIL BULK FLOWABLE | Shofu Dental Corporation | 2013-10-03 | Traditional | PDF ↗ |
| K130841 | SHOFU BLOCK HC | Shofu Dental Corporation | 2013-09-11 | Traditional | PDF ↗ |
| K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | Pac-Dent International, Inc. | 2013-08-13 | Traditional | PDF ↗ |
| K123631 | MFP-051 | GC America, Inc. | 2013-07-23 | Traditional | PDF ↗ |
| K131504 | UNIVERSAL OPAQUE | Shofu Dental Corporation | 2013-07-16 | Traditional | PDF ↗ |
| K123823 | INTERLIG | Angelus Industria DE Productos Odontologicos | 2013-05-31 | Traditional | PDF ↗ |
| K130371 | CLEARFIL MAJESTY ES FLOW | Kuraray Noritake Dental, Inc. | 2013-04-09 | Traditional | PDF ↗ |
| K121769 | DENTOCORE / DENTOCORE BODY | Itena Clinical | 2013-03-05 | Abbreviated | PDF ↗ |
| K121735 | FIBER DISK AND BLOCK PERMANENT, TRINIA | Bioloren S.R.L. | 2013-02-21 | Traditional | PDF ↗ |
| K123397 | MULTILINK AUTOMIX | Ivoclar Vivadent, AG | 2013-01-31 | Traditional | PDF ↗ |
| K123304 | SR NEXCO PASTE LAYERING MATERIALS, SR NEXCO OPAQUER, SR NEXCO LINER-SR NEXCO CONNECT, SR NEXCO STAINS, SR NEXCO RETENTIO | Ivoclar Vivadent, AG | 2013-01-24 | Abbreviated | PDF ↗ |
| K123773 | X-TRA BASE | Voco GmbH | 2012-12-21 | Traditional | PDF ↗ |
| K120237 | BPA-FREE MICROHYBID COMPOSITE | Novocol, Inc. | 2012-12-11 | Abbreviated | PDF ↗ |
| K121915 | BRIGHT RESTORATIVE MATERIALS | Dmp, Ltd. | 2012-09-28 | Traditional | PDF ↗ |
| K121880 | DMRC NANOFLOW DMRC NANOCOMPOSITE EBOND SURE ETCH GEL SURE ETCH LIQUID | Danville Materials, Inc. | 2012-09-25 | Traditional | PDF ↗ |
| K122569 | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR | 3M Company | 2012-09-12 | Traditional | PDF ↗ |
| K121230 | IPS EMPRESS DIRECT COLOR IPS EMPRESS DIRECT OPAQUE | Ivoclar Vivadent, AG | 2012-08-29 | Traditional | PDF ↗ |
| K121583 | CLEARFIL MAJESTY FLOW | Kuraray Noritake Dental, Inc. | 2012-07-25 | Traditional | PDF ↗ |
| K120768 | ES FLOW | Spident Co., Ltd. | 2012-05-03 | Traditional | PDF ↗ |
| K120453 | FILTEK BULK FILL FLOWABLE RESTORATIVE | 3M Espe Dental Products | 2012-03-19 | Traditional | PDF ↗ |
| K113617 | SPEE-DEE PATCH | Pulpdent Corporation | 2012-03-02 | Traditional | PDF ↗ |
| K112044 | ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A | Anaxdent GmbH | 2012-01-26 | Abbreviated | PDF ↗ |
| K113563 | N-HYBRIDE-COMPOSITE LC | Voco GmbH | 2011-12-21 | Special | PDF ↗ |
| K113444 | N-HYBRIDE-COMPOSITE LC FLOW | Voco GmbH | 2011-12-21 | Special | PDF ↗ |
| K112501 | VENUS PEARL PLT REFILL A1 | Heraeus Kulzer, LLC | 2011-12-14 | Traditional | PDF ↗ |
| K112168 | COMPONEER | Coltene/Whaledent AG | 2011-11-21 | Traditional | PDF ↗ |
| K111982 | CLEARFIL DC CORE PLUS | Kuraray America, Inc. | 2011-11-17 | Traditional | PDF ↗ |
| K112447 | GRANDIO CORE DUAL CURE | Voco GmbH | 2011-11-08 | Traditional | PDF ↗ |
| K112374 | X-TRA BASE | Voco GmbH | 2011-10-20 | Traditional | PDF ↗ |
| K111958 | TETRIC EVOCERAM BULK FILL | Ivoclar Vivadent, Inc. | 2011-10-14 | Traditional | PDF ↗ |
| K110859 | METAL OPAQUER | Apex Dental Materials, Inc. | 2011-06-23 | Traditional | PDF ↗ |
| K110642 | SILJETR SYSTEM | Danville Materials, Inc. | 2011-05-27 | Traditional | PDF ↗ |
| K110589 | CIMARA | Voco GmbH | 2011-05-27 | Traditional | PDF ↗ |
| K110178 | ESTELITE COLOR | Tokuyama Dental Corporation | 2011-04-05 | Traditional | PDF ↗ |
| K103528 | IPS EMPRESS DIRECT FLOW | Ivoclar Vivadent, Inc. | 2011-02-25 | Traditional | PDF ↗ |
| K110428 | ESCOM 100 | Spident Co., Ltd. | 2011-02-25 | Traditional | PDF ↗ |
| K103190 | PROFIL COMPOSITES (PROFIL, PROFIL FLOW) | Silmet , Ltd. | 2011-02-02 | Traditional | PDF ↗ |
| K103580 | GRANDIO SO FLOW | Voco GmbH | 2011-01-21 | Special | PDF ↗ |
| K110131 | LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE | 3M Espe Dental Products | 2011-01-21 | Traditional | PDF ↗ |
| K103351 | DMC COMPOSITE 2 | Kerr Corporation | 2011-01-20 | Traditional | PDF ↗ |
| K102703 | BUILD-IT TOTAL CORE | Pentron Clinical | 2011-01-05 | Traditional | PDF ↗ |
| K102984 | AURA | Sdi Limited | 2010-12-08 | Traditional | PDF ↗ |
| K102255 | DMP ETCHING GEL | Dmp, Ltd. | 2010-11-23 | Traditional | PDF ↗ |
| K102257 | NANOCERAM- BRIGHT | Dmp, Ltd. | 2010-11-19 | Traditional | PDF ↗ |
| K102603 | SA FLOWABLE ADHESIVE | Dmg USA, Inc. | 2010-11-17 | Abbreviated | PDF ↗ |
| K102354 | GRANDIO SO HEAVY FLOW | Voco GmbH | 2010-11-08 | Special | PDF ↗ |
| K102351 | GRANDIO SO | Voco GmbH | 2010-11-02 | Special | PDF ↗ |
| K101540 | GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE | Novocol Inc. Dba Septodont and Confi-Dental Produc | 2010-10-29 | Abbreviated | PDF ↗ |
| K102526 | BLO2X OXYGEN BLOCKER | Pascal Co., Inc. | 2010-10-22 | Traditional | PDF ↗ |
| K102450 | IONOLUX PRO | Voco GmbH | 2010-10-08 | Special | PDF ↗ |
| K101603 | BEAUTIFIL FLOW PLUS | Shofu Dental Corp. | 2010-08-23 | Traditional | PDF ↗ |
| K101621 | LITE ART | Shofu Dental Corp. | 2010-08-23 | Traditional | PDF ↗ |
| K101213 | GRANDIO FLOW | Voco GmbH | 2010-08-19 | Traditional | PDF ↗ |
| K101215 | NUANCE | Discus Dental, LLC | 2010-05-12 | Traditional | PDF ↗ |
| K100235 | FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE | 3M Company | 2010-05-12 | Traditional | PDF ↗ |
| K100083 | ESTHETICA | Kerr Corporation | 2010-03-19 | Traditional | PDF ↗ |
| K100328 | CLEARFIL MAJETY POSTERIOR | Kuraray Medical, Inc. | 2010-03-05 | Special | PDF ↗ |
| K100413 | TEMP IT | Spident Co., Ltd. | 2010-03-03 | Traditional | PDF ↗ |
| K093470 | CORE-FLO D/C | Bisco, Inc. | 2010-02-17 | Traditional | PDF ↗ |
| K093484 | PREMISE FLOWABLE MODIFIED | Kerr Corporation | 2010-01-27 | Traditional | PDF ↗ |
| K092912 | STARFILL 2B HV (HIGH VISCOSITY) ROCKCORE, MODEL: 90838 AND STARFILL 2B LV (LOW VISCOSITY), MODEL: 90150 | Danville Materials, Inc. | 2009-12-16 | Traditional | PDF ↗ |
| K092730 | COSMEDENT BRUSHABLE COMPOSITE | Cosmedent, Inc. | 2009-11-20 | Traditional | PDF ↗ |
| K092501 | LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL | Novocol, Inc. | 2009-11-12 | Abbreviated | PDF ↗ |
| K091512 | BUILD-IT LIGHT CURE | Pentron Clinical Technologies | 2009-10-30 | Traditional | PDF ↗ |
| K092281 | CLEARFIL MAJESTY POSTERIOR PLT | Kuraray Medical, Inc. | 2009-10-27 | Traditional | PDF ↗ |
| K091091 | SONICFILL 2010 | Sybron Dental Specialties, Inc. | 2009-10-14 | Traditional | PDF ↗ |
| K092539 | SEAMFREE | Apex Dental Materials, Inc. | 2009-10-01 | Traditional | PDF ↗ |
| K091647 | INJECTAFIL | Apex Dental Materials, Inc. | 2009-09-21 | Traditional | PDF ↗ |
| K091635 | VENUS DIAMOND FLOW | Heraeus Kulzer, LLC | 2009-09-03 | Abbreviated | PDF ↗ |
| K092572 | CORE*IT DUAL | Spident Co., Ltd. | 2009-08-26 | Traditional | PDF ↗ |
| K091388 | GCUC-505 | GC America, Inc. | 2009-07-22 | Traditional | PDF ↗ |
| K090843 | AMARIS GINGIVA OPAQUER | Voco GmbH | 2009-06-17 | Traditional | PDF ↗ |
| K090704 | MULTILINK IMPLANT | Ivoclar Vivadent, Inc. | 2009-06-17 | Traditional | PDF ↗ |
| K090747 | MI FLOW (GCUC-450) | GC America, Inc. | 2009-06-10 | Traditional | PDF ↗ |
| K091023 | METAMORPHOSIS | Kerr Corporation | 2009-05-21 | Traditional | PDF ↗ |
| K090391 | PULPDENT MICRO-HYBRID COMPOSITE | Pulpdent Corporation | 2009-05-11 | Traditional | PDF ↗ |
| K090701 | EMPRESS DIRECT | Ivoclar Vivadent, Inc. | 2009-04-29 | Traditional | PDF ↗ |
| K083841 | ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL | Dentsply International, Inc. | 2009-04-14 | Traditional | PDF ↗ |
| K090292 | PREMISE MODIFIED | Kerr Corp. | 2009-04-03 | Traditional | PDF ↗ |
| K083326 | FLUOROCORE 2 | Dentsply International, Inc. | 2009-02-10 | Traditional | PDF ↗ |
| K083610 | FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE | 3M Company | 2008-12-17 | Traditional | PDF ↗ |
| K082671 | HERCULITE ULTRA | Sybron Dental Specialties | 2008-12-11 | Traditional | PDF ↗ |
| K082434 | GDLS-200 | GC America, Inc. | 2008-11-14 | Traditional | PDF ↗ |
| K082171 | GRADIA CORE | GC America, Inc. | 2008-10-30 | Traditional | PDF ↗ |
| K081695 | DMC COMPOSITE | Kerr Corp. | 2008-08-12 | Traditional | PDF ↗ |
| K073047 | APROXI 1100 AND 4000 SERIES DENTAL INLAYS | Aproxi Aps | 2008-08-07 | Abbreviated | PDF ↗ |
| K080940 | ESTELITE SIGMA QUICK | Tokuyama Dental Corporation | 2008-06-19 | Traditional | PDF ↗ |
| K080478 | GRADIA FORTE | GC America, Inc. | 2008-06-05 | Traditional | PDF ↗ |
| K080480 | NANOCOMPOSITE RESTORATIVE KIT | Dmg USA, Inc. | 2008-05-30 | Abbreviated | PDF ↗ |
| K080305 | NEXCOMP AND META ETCHANT | Meta Biomed Co., Ltd. | 2008-04-07 | Traditional | PDF ↗ |
| K080068 | BEAUTIFIL OPAQUER | Shofu Dental Corp. | 2008-02-28 | Traditional | PDF ↗ |
| K072733 | 3M ESPE ADULT CROWN | 3M Company | 2008-02-15 | Traditional | PDF ↗ |
| K080265 | DENFIL ETCHANT-37 | Vericom Co., Ltd. | 2008-02-06 | Traditional | PDF ↗ |
| K073554 | NEUN | Heraeus Kulzer,GmbH | 2008-02-04 | Traditional | PDF ↗ |
| K072746 | E-1 ESTHETIC COMPOSITE SYSTEM | Tokuyama Dental Corporation | 2007-12-04 | Traditional | PDF ↗ |
| K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | Pentron Clinical Technologies | 2007-10-26 | Traditional | PDF ↗ |
| K072069 | SPACER | Vericom Co., Ltd. | 2007-09-28 | Traditional | PDF ↗ |
| K072150 | DIMER ACID DERIVED NANO-HYBRID COMPOSITE RESTORATIVE MATERIAL | Novocol, Inc. | 2007-09-13 | Abbreviated | PDF ↗ |
| K071742 | BEAUTIFIL II | Shofu Dental Corp. | 2007-08-15 | Traditional | PDF ↗ |
| K071288 | MODIFICATION TO KAVO QUATTROCARE | Sybron Dental Specialties, Inc. | 2007-07-19 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.