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 |
|---|---|---|---|
| Feb 10, 1984 | K834247 | MATERIAL TOOTHSADE RESIN Scientific Pharmaceuticals, Inc. | EBF |
| Feb 3, 1984 | K834046 | LUXENE VINYL-JECT 3600-80 Howmedica Corp. | EBF |
| Feb 3, 1984 | K833757 | VISIO-GEM Espe GmbH (Us) | EBF |
| Nov 14, 1983 | K831351 | PERMALUX VISIBLE CURE COMPOSITE RESTOR Lares Manufacturing Co., Inc. | EBF |
| Oct 19, 1983 | K832781 | CURAY-SUPPORT, CORE BUILD-UP MATERIAL Scientific Pharmaceuticals, Inc. | EBF |
| Sep 12, 1983 | K831215 | DENTACOLOR LIGHT CURING CROWN & BRIDGE Kulzer, Inc. | EBF |
| Aug 31, 1983 | K832062 | ADAPTIC*FAST SET DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Aug 31, 1983 | K832061 | LIGHT CURING BONDING AGENT Johnson & Johnson Professionals, Inc. | EBF |
| Jul 28, 1983 | K831484 | COMPOSI-GLAZE Denpac Corp. | EBF |
| Jun 30, 1983 | K831559 | CERTAIN *DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| May 9, 1983 | K830513 | FIRST TM Phasealloy | EBF |
| Mar 17, 1983 | K830442 | PRISMA-FINE Dentsply Intl. | EBF |
| Mar 17, 1983 | K830380 | MICRODAPT DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Dec 28, 1982 | K823510 | CURAY ANTERIOR/POSTERIOR RESTORATIVE Scientific Pharmaceuticals, Inc. | EBF |
| Nov 22, 1982 | K823185 | GAMMA LIGHT CURING DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Sep 14, 1982 | K822453 | VISIO-OPAQUER Espe GmbH (Us) | EBF |
| Sep 14, 1982 | K822450 | AURAFILL* DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Jul 16, 1982 | K821895 | AH-1 LIGHT-CURE DENTAL COMPOSITE RESTOR American Midwest | EBF |
| Mar 11, 1982 | K820028 | ZEON COMPOSITE RESIN LIGHT CURE SYS National Patent Development Corp. | EBF |
| Mar 2, 1982 | K820182 | SYBRON/KERR COMMAND Sybron Corp. | EBF |
| Jan 29, 1982 | K813568 | ESTILUX POSTERIOR XR Kulzer, Inc. | EBF |
| Jan 22, 1982 | K820006 | ZEON COMPOSITE RESIN SYSTEM National Patent Development Corp. | EBF |
| Jan 7, 1982 | K813357 | CAULK OPAQUER Dentsply Intl. | EBF |
| Nov 24, 1981 | K813090 | COMPOSITE DENTAL RESTORATIVE MATERIAL Sci-Pharm, Inc. | EBF |
| Nov 17, 1981 | K812889 | ESTILUX POSTERIOR Kulzer, Inc. | EBF |
| Sep 25, 1981 | K812546 | BEAUDENT Sci-Pharm, Inc. | EBF |
| Sep 25, 1981 | K812545 | BEAUFILL Sci-Pharm, Inc. | EBF |
| Sep 25, 1981 | K812449 | ADAPTIC* C.F.S. Johnson & Johnson Professionals, Inc. | EBF |
| Sep 23, 1981 | K812551 | BEAUCOR Sci-Pharm, Inc. | EBF |
| Sep 8, 1981 | K812169 | VISIO-FIL Espe GmbH (Us) | EBF |
| Aug 31, 1981 | K812119 | NIMETIC-DISPERS Espe-Premier Sales Co. | EBF |
| Aug 20, 1981 | K811427 | SUPERFIL LIGHT & SUPERFIL BONDING SYSTEM Harry J. Bosworth Co. | EBF |
| Aug 18, 1981 | K811979 | ATT-1 DENTAL COMPOSITE RESTORATIVE SYS American Midwest | EBF |
| Jul 1, 1981 | K811669 | DURAFILL MICROFILL RESTORATIVE MATERIAL Kulzer, Inc. | EBF |
| Jun 16, 1981 | K811443 | ENHANCE DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Jun 16, 1981 | K811363 | COLTENE DRS DENTAL RESTORATIVE SYSTEM Coltene, Inc. | EBF |
| May 5, 1981 | K810969 | ISOSIT C & B MATERIAL Bauer, Cheng & Associates, Inc. | EBF |
| Mar 24, 1981 | K810595 | SILUX RESTORATIVE MATERIAL & ENAMEL BOND 3M Company | EBF |
| Mar 17, 1981 | K810479 | SUPPORT Sci-Pharm, Inc. | EBF |
| Jan 14, 1981 | K803227 | VISIO-DISPERS Espe-Premier Sales Co. | EBF |
| Jan 14, 1981 | K802975 | ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE Dentsply Intl. | EBF |
| Dec 18, 1980 | K802535 | HYDROXYLATE DENTAL COMPOSITE RESTROATIVE Wallace A. Erickson & Co. | EBF |
| Nov 24, 1980 | K802683 | HELIOSIT Vivadent (Usa), Inc. | EBF |
| Nov 12, 1980 | K802680 | ISOPAST-DS Vivadent (Usa), Inc. | EBF |
| Sep 16, 1980 | K802125 | ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE Dentsply Intl. | EBF |
| Sep 16, 1980 | K802049 | NIMETIC-DISPERS Espe Dental Products | EBF |
| Aug 7, 1980 | K801798 | COMPOSITE RESTORATIVE, PASTE/PASTE TYPE Scientific Pharmaceuticals, Inc. | EBF |
| Aug 7, 1980 | K801797 | SCI-PHARM PAINT-ON RESTORATIVE Scientific Pharmaceuticals, Inc. | EBF |
| Aug 7, 1980 | K801732 | PRISMA-FIL Dentsply Intl. | EBF |
| Aug 4, 1980 | K801529 | KERR CORE COMPOSITE Sybron Corp. | EBF |
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