EBF
934 FDA 510(k) clearances · Product code
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VERTEX ETCHANT (K010849) | Apex Dental Materials, Inc. | 2001-09-14 |
| ESTENIA (K012707) | Kuraray Medical, Inc. | 2001-09-13 |
| CLEARFIL PHOTO CORE (K012705) | Kuraray Medical, Inc. | 2001-09-11 |
| CLEARFIL ST OPAQUER (K012704) | Kuraray Medical, Inc. | 2001-09-10 |
| CLEARFIL CORE NEW BOND (K012703) | Kuraray Medical, Inc. | 2001-09-10 |
| A-WEAR (K012180) | Bisco, Inc. | 2001-09-05 |
| POINT 4 FLOWABLE (K012321) | Sybron Dental Specialties, Inc. | 2001-08-27 |
| LUXACORE/LUXACORE DUAL (K012307) | Dmg USA, Inc. | 2001-08-23 |
| CORERESTORE 2 (K011798) | Sybron Dental Specialties, Inc. | 2001-08-14 |
| TOOTH SHADE RESIN MATERIAL (K011453) | Rite-Dent Manufacturing Corp. | 2001-07-23 |
| ADMIRA FLOW (K011756) | Voco GmbH | 2001-07-18 |
| LUTE; CORE (K011517) | First Scientific Limited | 2001-07-10 |
| IN TEN-S (K011492) | Ivoclar North America, Inc. | 2001-07-05 |
| RESTORE-PF VIC; RESTORE-PF VLC CAPSULE (K011295) | First Scientific Limited | 2001-06-27 |
| LUTE VLC; CORE VLC (K011309) | First Scientific Limited | 2001-06-22 |
| FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW (K011211) | Dmg USA, Inc. | 2001-06-18 |
| D/C CORE MATERIAL (K010475) | Parkell, Inc. | 2001-05-07 |
| BEAUTIFIL (K010914) | Shofu Dental Corp. | 2001-04-20 |
| 3M ESPE HAUR (K010781) | 3M Company | 2001-04-13 |
| TOTAL CURE (K010196) | Bisco, Inc. | 2001-04-05 |
| TETRIC CERAM HB (K010250) | Ivoclar North America, Inc. | 2001-02-28 |
| PALFIQUE ESTELITE LV CLEAR (K010267) | Tokuyama America, Inc. | 2001-02-27 |
| CHALLENGER DIRECT COMPOSITE (K010219) | International Dental Research | 2001-02-21 |
| PALFIQUE ESTELITE LV (K002863) | Tokuyama America, Inc. | 2001-01-04 |
| COLTENE AURA COMPOMER RESTORATIVE SYSTEM (K003034) | Coltene/Whaledent, Inc. | 2000-11-30 |
| RENEW LS-2 (K003361) | Bisco, Inc. | 2000-11-28 |
| RENEW LS-1 (K003317) | Bisco, Inc. | 2000-11-21 |
| IMPROVED TRY-IN GEL (K001899) | Sybron Dental Specialties, Inc. | 2000-08-28 |
| PRIMAFLOW (K002086) | Dmg USA, Inc. | 2000-08-17 |
| DC-TELL (K001799) | Austenal, Inc. | 2000-08-10 |
| CLEARFIL ST OPAQUER (K001913) | Kuraray Company, Ltd. | 2000-08-04 |
| SCULPTURE FLOW (K001623) | Jeneric/Pentron, Inc. | 2000-07-11 |
| GRADIA (K001518) | GC America, Inc. | 2000-07-05 |
| SIGNUM (K001360) | J.F. Jelenko & Co., Inc. | 2000-06-20 |
| PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL (K001108) | Prime Dental Manufacturing, Inc. | 2000-05-30 |
| BELLEGLASS HP ENAMEL (K000530) | Sybron Dental Specialties, Inc. | 2000-05-17 |
| EZ CONNECT RESIN (K000357) | Kerr Dental Materials Center | 2000-04-28 |
| BELLEGLASS HP TRANSLUCENT DENTIN (K000436) | Sybron Dental Specialties, Inc. | 2000-03-24 |
| BELLEGLASS HP OPACEOUS DENTIN (K000269) | Sybron Dental Specialties, Inc. | 2000-03-23 |
| BUILD-IT FR (K000211) | Jeneric/Pentron, Inc. | 2000-03-17 |
| DEFINITE (K993514) | Degussa - Ney Dental, Inc. | 2000-02-24 |
| ARABESK FLOW (K994304) | Voco GmbH | 2000-02-07 |
| ARABESK TOP (K994268) | Voco GmbH | 2000-02-03 |
| PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL (K994224) | Prime Dental Manufacturing, Inc. | 2000-01-31 |
| RENAMEL SCULPT (K993658) | Cosmedent, Inc. | 2000-01-18 |
| RENAMEL PACK (K993659) | Cosmedent, Inc. | 2000-01-18 |
| ADMIRA (K994056) | Voco GmbH | 2000-01-12 |
| FUJI II LC CAPSULE (K993973) | GC America, Inc. | 2000-01-11 |
| KETAC-MOLAR QUICK (K994251) | Espe Dental AG | 2000-01-03 |
| SOLITAIRE 2 (K993932) | Heraeus Kulzer, Inc. | 1999-12-22 |
| PA GEL 35% IN BLUE AND PA GEL 10% IN GREEN OR BLUE (K993716) | Harry J. Bosworth Co. | 1999-12-21 |
| PRE-VISION FILL (K993602) | Heraeus Kulzer, Inc. | 1999-12-15 |
| TETRIC FLOW (K993783) | Ivoclar North America, Inc. | 1999-12-13 |
| PROMPTFLOW (K993566) | Espe Dental AG | 1999-12-06 |
| HYTAC (K992909) | Espe Dental AG | 1999-11-24 |
| LIGHT-CORE (K993488) | Bisco, Inc. | 1999-11-10 |
| ILLUSION (K993192) | Bisco, Inc. | 1999-10-27 |
| REFERENCE (K992966) | Espe Dental AG | 1999-10-07 |
| SINFONY (K992645) | Espe Dental AG | 1999-09-22 |
| LUMA LIGHT 2000 CURE LIGHT (K992102) | Lumalite, Inc. | 1999-08-31 |
| POST CEMENT HI-X (K992248) | Bisco, Inc. | 1999-08-25 |
| PRODIGY 4 TRANSLUCENT SHADES (K992118) | Sybron Dental Specialties, Inc. | 1999-08-18 |
| 3M LVR SYSTEM (K991961) | 3M Company | 1999-08-09 |
| ETCHING GEL (K991450) | Silicon-Und Composite Spezialitaten GmbH | 1999-07-09 |
| SELF CURE COMPOSITE (K991488) | Harry J. Bosworth Co. | 1999-06-21 |
| FLC COMPOSITE (K991491) | Harry J. Bosworth Co. | 1999-06-21 |
| LC MICROFILL (K991442) | S & C Polymer GmbH | 1999-06-03 |
| FLOW LINE (K990756) | Heraeus Kulzer, Inc. | 1999-05-07 |
| CAVIT LC (K990982) | Espe Dental AG | 1999-04-23 |
| PRODIGY 4 (K990898) | Sybron Dental Specialties, Inc. | 1999-04-06 |
| MULTI-CURE COMPOSITE CEMENT (K990314) | Medental Intl. | 1999-04-02 |
| LC FLOWFILL (K990108) | S & C Polymer GmbH | 1999-03-09 |
| MONOPAQUE (K990315) | Ivoclar North America, Inc. | 1999-03-04 |
| DC-CORE (K984097) | S & C Polymer GmbH | 1999-02-09 |
| LC MICROHYBRID (K984484) | S & C Polymer GmbH | 1999-01-20 |
| R-30 AESTHETIC RESTORATIVE (K984387) | Dentsply Intl. | 1999-01-13 |
| ADVENT (K984112) | Bisco, Inc. | 1998-12-22 |
| QUADRANT POSTERIOR DENSE (K984044) | Cavex Holland BV | 1998-12-16 |
| QUADRANT TOTAL ETCH (K984043) | Cavex Holland BV | 1998-12-04 |
| QUADRANT CORE LC (K984042) | Cavex Holland BV | 1998-12-04 |
| QUADRANT UNIVERSAL LC (K984041) | Cavex Holland BV | 1998-12-04 |
| QUADRANT UNICHEM (K983751) | Cavex Holland BV | 1998-11-30 |
| QUADRANT ANTERIOR SHINE (K983549) | Cavex Holland BV | 1998-11-23 |
| PRODIGY- 3 (K983370) | Sybron Dental Specialties, Inc. | 1998-11-18 |
| LOW VISCOSITY COMPOSITE TEMPORARY (PROVISIONAL) MATERIAL (K980800) | Cosmedent, Inc. | 1998-11-09 |
| ELAN-2 (K983091) | Kerr Dental Materials Center | 1998-10-28 |
| STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC (K982692) | Sterngold/Implamed | 1998-10-22 |
| CHROMA ZONE COLOR STAIN (K982259) | Kuraray America, Inc. | 1998-09-22 |
| RENEW (K982729) | Bisco, Inc. | 1998-09-15 |
| SPECTRUM 800 CURING UNIT (K982318) | Dentsply Intl. | 1998-09-15 |
| CHEMICAL CURE COMPOSITE WITH ENAMEL BOND (K982191) | Medental Intl. | 1998-09-14 |
| PYRAMID (K982645) | Bisco, Inc. | 1998-09-02 |
| APOLLO 95E (K981948) | Dental/Medical Diagnostic Systems, Inc. | 1998-08-18 |
| DYTRACT FLOW RESTORATIVE (K982395) | Dentsply Intl. | 1998-08-18 |
| ZENITH LUXACORE AUTOMIX CORE MATERIAL (MULTIPLE) (K982201) | Foremost Dental Mfg., Inc. | 1998-08-10 |
| ESTENIA (K982164) | Kuraray America, Inc. | 1998-08-10 |
| 3M DENT II SYSTEM (K981647) | 3M Company | 1998-08-09 |
| PRODIGY 2 (K982148) | Sybron Dental Specialties, Inc. | 1998-07-31 |
| SPLINE DENTAL IMPLANT SYSTEM - SPLINE XI IMPLANT (K981562) | Sulzer Calcitek, Inc. | 1998-07-30 |
| PERMACEM AUTOMIX LUTING CEMENT SYSTEM (K981813) | Foremost Dental Mfg., Inc. | 1998-07-10 |
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