Material, Tooth Shade, Resin
Regulation 872.3690
18510(k)s in 12 months (937 all time)
2recalls in 12 months (71 all time)
71recalls that name a 510(k)
Top companies in EBF
| Company | 510(k)s | Recalls |
|---|---|---|
| Kerr Corp. | 9 | 43 |
| Voco GmbH | 45 | 1 |
| Sybron Dental Specialties | 28 | 7 |
| Bisco, Inc. | 30 | 0 |
| Pulpdent Corp. | 29 | 0 |
| Scientific Pharmaceuticals, Inc. | 29 | 0 |
| Dentsply Intl. | 28 | 0 |
| Ivoclar North America, Inc. | 28 | 0 |
| Shofu Dental Corp. | 27 | 0 |
| GC America, Inc. | 24 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 27, 2001 | K012160 | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 Premier Dental Products Co. | EBF |
| Sep 14, 2001 | K012740 | CLEARFIL AP-X Kuraray Medical, Inc. | EBF |
| Sep 14, 2001 | K012737 | CHROMA ZONE COLOR STAIN Kuraray Medical, Inc. | EBF |
| Sep 14, 2001 | K010849 | VERTEX ETCHANT Apex Dental Materials, Inc. | EBF |
| Sep 13, 2001 | K012707 | ESTENIA Kuraray Medical, Inc. | EBF |
| Sep 11, 2001 | K012705 | CLEARFIL PHOTO CORE Kuraray Medical, Inc. | EBF |
| Sep 10, 2001 | K012704 | CLEARFIL ST OPAQUER Kuraray Medical, Inc. | EBF |
| Sep 10, 2001 | K012703 | CLEARFIL CORE NEW BOND Kuraray Medical, Inc. | EBF |
| Sep 5, 2001 | K012180 | A-WEAR Bisco, Inc. | EBF |
| Aug 27, 2001 | K012321 | POINT 4 FLOWABLE Sybron Dental Specialties, Inc. | EBF |
| Aug 23, 2001 | K012307 | LUXACORE/LUXACORE DUAL Dmg USA, Inc. | EBF |
| Aug 14, 2001 | K011798 | CORERESTORE 2 Sybron Dental Specialties, Inc. | EBF |
| Jul 23, 2001 | K011453 | TOOTH SHADE RESIN MATERIAL Rite-Dent Manufacturing Corp. | EBF |
| Jul 18, 2001 | K011756 | ADMIRA FLOW Voco GmbH | EBF |
| Jul 10, 2001 | K011517 | LUTE; CORE First Scientific Limited, GB | EBF |
| Jul 5, 2001 | K011492 | IN TEN-S Ivoclar North America, Inc. | EBF |
| Jun 27, 2001 | K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE First Scientific Limited, GB | EBF |
| Jun 22, 2001 | K011309 | LUTE VLC; CORE VLC First Scientific Limited, GB | EBF |
| Jun 18, 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW Dmg USA, Inc. | EBF |
| May 7, 2001 | K010475 | D/C CORE MATERIAL Parkell, Inc. | EBF |
| Apr 20, 2001 | K010914 | BEAUTIFIL Shofu Dental Corp. | EBF |
| Apr 13, 2001 | K010781 | 3M ESPE HAUR 3M Company | EBF |
| Apr 5, 2001 | K010196 | TOTAL CURE Bisco, Inc. | EBF |
| Feb 28, 2001 | K010250 | TETRIC CERAM HB Ivoclar North America, Inc. | EBF |
| Feb 27, 2001 | K010267 | PALFIQUE ESTELITE LV CLEAR Tokuyama America, Inc. | EBF |
| Feb 21, 2001 | K010219 | CHALLENGER DIRECT COMPOSITE International Dental Research | EBF |
| Jan 4, 2001 | K002863 | PALFIQUE ESTELITE LV Tokuyama America, Inc. | EBF |
| Nov 30, 2000 | K003034 | COLTENE AURA COMPOMER RESTORATIVE SYSTEM Coltene/Whaledent, Inc. | EBF |
| Nov 28, 2000 | K003361 | RENEW LS-2 Bisco, Inc. | EBF |
| Nov 21, 2000 | K003317 | RENEW LS-1 Bisco, Inc. | EBF |
| Aug 28, 2000 | K001899 | IMPROVED TRY-IN GEL Sybron Dental Specialties, Inc. | EBF |
| Aug 17, 2000 | K002086 | PRIMAFLOW Dmg USA, Inc. | EBF |
| Aug 10, 2000 | K001799 | DC-TELL Austenal, Inc. | EBF |
| Aug 4, 2000 | K001913 | CLEARFIL ST OPAQUER Kuraray Company, Ltd. | EBF |
| Jul 11, 2000 | K001623 | SCULPTURE FLOW Jeneric/Pentron, Inc. | EBF |
| Jul 5, 2000 | K001518 | GRADIA GC America, Inc. | EBF |
| Jun 20, 2000 | K001360 | SIGNUM J.F. Jelenko & Co., Inc. | EBF |
| May 30, 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL Prime Dental Manufacturing, Inc. | EBF |
| May 17, 2000 | K000530 | BELLEGLASS HP ENAMEL Sybron Dental Specialties, Inc. | EBF |
| Apr 28, 2000 | K000357 | EZ CONNECT RESIN Kerr Dental Materials Center | EBF |
| Mar 24, 2000 | K000436 | BELLEGLASS HP TRANSLUCENT DENTIN Sybron Dental Specialties, Inc. | EBF |
| Mar 23, 2000 | K000269 | BELLEGLASS HP OPACEOUS DENTIN Sybron Dental Specialties, Inc. | EBF |
| Mar 17, 2000 | K000211 | BUILD-IT FR Jeneric/Pentron, Inc. | EBF |
| Feb 24, 2000 | K993514 | DEFINITE Degussa - Ney Dental, Inc. | EBF |
| Feb 7, 2000 | K994304 | ARABESK FLOW Voco GmbH | EBF |
| Feb 3, 2000 | K994268 | ARABESK TOP Voco GmbH | EBF |
| Jan 31, 2000 | K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL Prime Dental Manufacturing, Inc. | EBF |
| Jan 18, 2000 | K993659 | RENAMEL PACK Cosmedent, Inc. | EBF |
| Jan 18, 2000 | K993658 | RENAMEL SCULPT Cosmedent, Inc. | EBF |
| Jan 12, 2000 | K994056 | ADMIRA Voco GmbH | EBF |
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