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 5 of 10
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 | Premier Dental Products Co. | 2001-09-27 | Traditional | PDF ↗ |
| K012737 | CHROMA ZONE COLOR STAIN | Kuraray Medical, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K010849 | VERTEX ETCHANT | Apex Dental Materials, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K012740 | CLEARFIL AP-X | Kuraray Medical, Inc. | 2001-09-14 | Traditional | PDF ↗ |
| K012707 | ESTENIA | Kuraray Medical, Inc. | 2001-09-13 | Traditional | PDF ↗ |
| K012705 | CLEARFIL PHOTO CORE | Kuraray Medical, Inc. | 2001-09-11 | Traditional | PDF ↗ |
| K012704 | CLEARFIL ST OPAQUER | Kuraray Medical, Inc. | 2001-09-10 | Traditional | PDF ↗ |
| K012703 | CLEARFIL CORE NEW BOND | Kuraray Medical, Inc. | 2001-09-10 | Traditional | PDF ↗ |
| K012180 | A-WEAR | Bisco, Inc. | 2001-09-05 | Traditional | PDF ↗ |
| K012321 | POINT 4 FLOWABLE | Sybron Dental Specialties, Inc. | 2001-08-27 | Traditional | PDF ↗ |
| K012307 | LUXACORE/LUXACORE DUAL | Dmg USA, Inc. | 2001-08-23 | Abbreviated | PDF ↗ |
| K011798 | CORERESTORE 2 | Sybron Dental Specialties, Inc. | 2001-08-14 | Traditional | PDF ↗ |
| K011453 | TOOTH SHADE RESIN MATERIAL | Rite-Dent Manufacturing Corp. | 2001-07-23 | Traditional | PDF ↗ |
| K011756 | ADMIRA FLOW | Voco GmbH | 2001-07-18 | Traditional | PDF ↗ |
| K011517 | LUTE; CORE | First Scientific Limited | 2001-07-10 | Traditional | PDF ↗ |
| K011492 | IN TEN-S | Ivoclar North America, Inc. | 2001-07-05 | Traditional | PDF ↗ |
| K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | First Scientific Limited | 2001-06-27 | Traditional | PDF ↗ |
| K011309 | LUTE VLC; CORE VLC | First Scientific Limited | 2001-06-22 | Traditional | PDF ↗ |
| K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Dmg USA, Inc. | 2001-06-18 | Traditional | PDF ↗ |
| K010475 | D/C CORE MATERIAL | Parkell, Inc. | 2001-05-07 | Traditional | PDF ↗ |
| K010914 | BEAUTIFIL | Shofu Dental Corp. | 2001-04-20 | Traditional | PDF ↗ |
| K010781 | 3M ESPE HAUR | 3M Company | 2001-04-13 | Traditional | PDF ↗ |
| K010196 | TOTAL CURE | Bisco, Inc. | 2001-04-05 | Traditional | PDF ↗ |
| K010250 | TETRIC CERAM HB | Ivoclar North America, Inc. | 2001-02-28 | Traditional | PDF ↗ |
| K010267 | PALFIQUE ESTELITE LV CLEAR | Tokuyama America, Inc. | 2001-02-27 | Traditional | PDF ↗ |
| K010219 | CHALLENGER DIRECT COMPOSITE | International Dental Research | 2001-02-21 | Special | PDF ↗ |
| K002863 | PALFIQUE ESTELITE LV | Tokuyama America, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM | Coltene/Whaledent, Inc. | 2000-11-30 | Traditional | PDF ↗ |
| K003361 | RENEW LS-2 | Bisco, Inc. | 2000-11-28 | Traditional | PDF ↗ |
| K003317 | RENEW LS-1 | Bisco, Inc. | 2000-11-21 | Traditional | PDF ↗ |
| K001899 | IMPROVED TRY-IN GEL | Sybron Dental Specialties, Inc. | 2000-08-28 | Traditional | PDF ↗ |
| K002086 | PRIMAFLOW | Dmg USA, Inc. | 2000-08-17 | Abbreviated | PDF ↗ |
| K001799 | DC-TELL | Austenal, Inc. | 2000-08-10 | Traditional | PDF ↗ |
| K001913 | CLEARFIL ST OPAQUER | Kuraray Company, Ltd. | 2000-08-04 | Traditional | PDF ↗ |
| K001623 | SCULPTURE FLOW | Jeneric/Pentron, Inc. | 2000-07-11 | Traditional | PDF ↗ |
| K001518 | GRADIA | GC America, Inc. | 2000-07-05 | Traditional | PDF ↗ |
| K001360 | SIGNUM | J.F. Jelenko & Co., Inc. | 2000-06-20 | Traditional | PDF ↗ |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | 2000-05-30 | Traditional | PDF ↗ |
| K000530 | BELLEGLASS HP ENAMEL | Sybron Dental Specialties, Inc. | 2000-05-17 | Traditional | PDF ↗ |
| K000357 | EZ CONNECT RESIN | Kerr Dental Materials Center | 2000-04-28 | Traditional | PDF ↗ |
| K000436 | BELLEGLASS HP TRANSLUCENT DENTIN | Sybron Dental Specialties, Inc. | 2000-03-24 | Traditional | PDF ↗ |
| K000269 | BELLEGLASS HP OPACEOUS DENTIN | Sybron Dental Specialties, Inc. | 2000-03-23 | Traditional | PDF ↗ |
| K000211 | BUILD-IT FR | Jeneric/Pentron, Inc. | 2000-03-17 | Traditional | PDF ↗ |
| K993514 | DEFINITE | Degussa - Ney Dental, Inc. | 2000-02-24 | Traditional | PDF ↗ |
| K994304 | ARABESK FLOW | Voco GmbH | 2000-02-07 | Traditional | PDF ↗ |
| K994268 | ARABESK TOP | Voco GmbH | 2000-02-03 | Traditional | PDF ↗ |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | Prime Dental Manufacturing, Inc. | 2000-01-31 | Traditional | PDF ↗ |
| K993659 | RENAMEL PACK | Cosmedent, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K993658 | RENAMEL SCULPT | Cosmedent, Inc. | 2000-01-18 | Traditional | PDF ↗ |
| K994056 | ADMIRA | Voco GmbH | 2000-01-12 | Traditional | PDF ↗ |
| K993973 | FUJI II LC CAPSULE | GC America, Inc. | 2000-01-11 | Traditional | PDF ↗ |
| K994251 | KETAC-MOLAR QUICK | Espe Dental AG | 2000-01-03 | Special | PDF ↗ |
| K993932 | SOLITAIRE 2 | Heraeus Kulzer, Inc. | 1999-12-22 | Traditional | PDF ↗ |
| K993716 | PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE | Harry J. Bosworth Co. | 1999-12-21 | Traditional | PDF ↗ |
| K993602 | PRE-VISION FILL | Heraeus Kulzer, Inc. | 1999-12-15 | Traditional | PDF ↗ |
| K993783 | TETRIC FLOW | Ivoclar North America, Inc. | 1999-12-13 | Traditional | PDF ↗ |
| K993566 | PROMPTFLOW | Espe Dental AG | 1999-12-06 | Traditional | PDF ↗ |
| K992909 | HYTAC | Espe Dental AG | 1999-11-24 | Traditional | PDF ↗ |
| K993488 | LIGHT-CORE | Bisco, Inc. | 1999-11-10 | Traditional | PDF ↗ |
| K993192 | ILLUSION | Bisco, Inc. | 1999-10-27 | Traditional | PDF ↗ |
| K992966 | REFERENCE | Espe Dental AG | 1999-10-07 | Traditional | PDF ↗ |
| K992645 | SINFONY | Espe Dental AG | 1999-09-22 | Traditional | PDF ↗ |
| K992102 | LUMA LIGHT 2000 CURE LIGHT | Lumalite, Inc. | 1999-08-31 | Traditional | PDF ↗ |
| K992248 | POST CEMENT HI-X | Bisco, Inc. | 1999-08-25 | Traditional | PDF ↗ |
| K992118 | PRODIGY 4 TRANSLUCENT SHADES | Sybron Dental Specialties, Inc. | 1999-08-18 | Traditional | PDF ↗ |
| K991961 | 3M LVR SYSTEM | 3M Company | 1999-08-09 | Traditional | PDF ↗ |
| K991450 | ETCHING GEL | Silicon-Und Composite Spezialitaten GmbH | 1999-07-09 | Traditional | PDF ↗ |
| K991488 | SELF CURE COMPOSITE | Harry J. Bosworth Co. | 1999-06-21 | Traditional | PDF ↗ |
| K991491 | FLC COMPOSITE | Harry J. Bosworth Co. | 1999-06-21 | Traditional | PDF ↗ |
| K991442 | LC MICROFILL | S & C Polymer GmbH | 1999-06-03 | Traditional | PDF ↗ |
| K990756 | FLOW LINE | Heraeus Kulzer, Inc. | 1999-05-07 | Traditional | PDF ↗ |
| K990982 | CAVIT LC | Espe Dental AG | 1999-04-23 | Traditional | PDF ↗ |
| K990898 | PRODIGY 4 | Sybron Dental Specialties, Inc. | 1999-04-06 | Traditional | PDF ↗ |
| K990314 | MULTI-CURE COMPOSITE CEMENT | Medental Intl. | 1999-04-02 | Traditional | PDF ↗ |
| K990108 | LC FLOWFILL | S & C Polymer GmbH | 1999-03-09 | Traditional | PDF ↗ |
| K990315 | MONOPAQUE | Ivoclar North America, Inc. | 1999-03-04 | Traditional | PDF ↗ |
| K984097 | DC-CORE | S & C Polymer GmbH | 1999-02-09 | Traditional | PDF ↗ |
| K984484 | LC MICROHYBRID | S & C Polymer GmbH | 1999-01-20 | Traditional | PDF ↗ |
| K984387 | R-30 AESTHETIC RESTORATIVE | Dentsply Intl. | 1999-01-13 | Traditional | PDF ↗ |
| K984112 | ADVENT | Bisco, Inc. | 1998-12-22 | Traditional | PDF ↗ |
| K984044 | QUADRANT POSTERIOR DENSE | Cavex Holland BV | 1998-12-16 | Traditional | PDF ↗ |
| K984042 | QUADRANT CORE LC | Cavex Holland BV | 1998-12-04 | Traditional | PDF ↗ |
| K984041 | QUADRANT UNIVERSAL LC | Cavex Holland BV | 1998-12-04 | Traditional | PDF ↗ |
| K984043 | QUADRANT TOTAL ETCH | Cavex Holland BV | 1998-12-04 | Traditional | PDF ↗ |
| K983751 | QUADRANT UNICHEM | Cavex Holland BV | 1998-11-30 | Traditional | PDF ↗ |
| K983549 | QUADRANT ANTERIOR SHINE | Cavex Holland BV | 1998-11-23 | Traditional | PDF ↗ |
| K983370 | PRODIGY- 3 | Sybron Dental Specialties, Inc. | 1998-11-18 | Traditional | PDF ↗ |
| K980800 | LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL | Cosmedent, Inc. | 1998-11-09 | Traditional | PDF ↗ |
| K983091 | ELAN-2 | Kerr Dental Materials Center | 1998-10-28 | Traditional | PDF ↗ |
| K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | Sterngold/Implamed | 1998-10-22 | Abbreviated | PDF ↗ |
| K982259 | CHROMA ZONE COLOR STAIN | Kuraray America, Inc. | 1998-09-22 | Traditional | PDF ↗ |
| K982318 | SPECTRUM 800 CURING UNIT | Dentsply Intl. | 1998-09-15 | Traditional | PDF ↗ |
| K982729 | RENEW | Bisco, Inc. | 1998-09-15 | Traditional | PDF ↗ |
| K982191 | CHEMICAL CURE COMPOSITE WITH ENAMEL BOND | Medental Intl. | 1998-09-14 | Traditional | PDF ↗ |
| K982645 | PYRAMID | Bisco, Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K981948 | APOLLO 95E | Dental/Medical Diagnostic Systems, Inc. | 1998-08-18 | Traditional | PDF ↗ |
| K982395 | DYTRACT FLOW RESTORATIVE | Dentsply Intl. | 1998-08-18 | Traditional | PDF ↗ |
| K982201 | ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) | Foremost Dental Mfg., Inc. | 1998-08-10 | Traditional | PDF ↗ |
| K982164 | ESTENIA | Kuraray America, Inc. | 1998-08-10 | Traditional | PDF ↗ |
| K981647 | 3M DENT II SYSTEM | 3M Company | 1998-08-09 | Traditional | PDF ↗ |
Product code EBF · Class II · Dental. Data: openFDA.