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 |
|---|---|---|---|
| Jul 8, 1994 | K942767 | ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN Wallace A. Erickson & Co. | EBF |
| Jul 5, 1994 | K941899 | SDI COMPOSTIES Southern Dental Industries, Inc. | EBF |
| Jun 10, 1994 | K942031 | CAULK TOOTH CONDITIONER GEL AND SYRINGE Dentsply Intl. | EBF |
| Jun 3, 1994 | K940737 | EDTA GEL (TM) Karolinska Institutet | EBF |
| May 3, 1994 | K941377 | CONQUEST SMOOTH TOUCH Jeneric/Pentron, Inc. | EBF |
| May 3, 1994 | K941373 | PENT CORE PLUS (PASTE-PASTE) Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941378 | PROCOM Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941376 | CONQUEST SENIOR Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941375 | CONQUEST GINGA-BLEND Jeneric/Pentron, Inc. | EBF |
| May 2, 1994 | K941374 | CONQUEST PRELUDE Jeneric/Pentron, Inc. | EBF |
| Apr 7, 1994 | K940800 | DENTACOLOR VITA (VS) SHADE SYSTEM Heraeus Kulzer, Inc. | EBF |
| Feb 22, 1994 | K930584 | MAGNACORE Scientific Pharmaceuticals, Inc. | EBF |
| Feb 22, 1994 | K930583 | MEGABOND SYSTEM Scientific Pharmaceuticals, Inc. | EBF |
| Feb 3, 1994 | K932828 | CENTRIX'S ENCORE SOLO LIGHT ACTIVATED RESIN CORE Alpha-Dent | EBF |
| Jan 28, 1994 | K932829 | CENTRIX'S ENCORE NATURAL COMPOSITE RESIN CORE PAST Alpha-Dent | EBF |
| Jan 28, 1994 | K932826 | CENTRIX'S ENCORE COMPOSITE RESIN CORE PASTE W\FLUO Alpha-Dent | EBF |
| Jan 26, 1994 | K935736 | CHARISMA SUPERLIGHT Heraeus Kulzer, Inc. | EBF |
| Jan 26, 1994 | K933766 | HIGH-Q-BOND Silmet U.S.A. Corp. | EBF |
| Jan 26, 1994 | K922252 | TI-CORE NEW & IMPROVED Essential Dental Systems, Inc. | EBF |
| Jan 26, 1994 | K922251 | TI-CORE-NATURAL Essential Dental Systems, Inc. | EBF |
| Jan 18, 1994 | K935032 | ZENITH TOTAL ETCH 10% PHOSPHORIC ACID Foremost Dental Mfg., Inc. | EBF |
| Nov 29, 1993 | K934247 | BISCO UNIVERSAL HYBRID COMPOSITE Bisco, Inc. | EBF |
| Nov 17, 1993 | K934611 | STO2P Ivoclar North America, Inc. | EBF |
| Nov 17, 1993 | K933656 | JEDENTAL PSROFILL SELF-CURE COMPOSITE Jedental Co., Inc. | EBF |
| Oct 7, 1993 | K930128 | SR SPECTRASIT, SR CHROMASIT Ivoclar North America, Inc. | EBF |
| Sep 29, 1993 | K932886 | ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE Wallace A. Erickson & Co. | EBF |
| Sep 23, 1993 | K932827 | ALPHA-DENT CORE BUILDUP PASTE Alpha-Dent | EBF |
| Sep 15, 1993 | K932154 | CONQUEST CRYSTAL Jeneric/Pentron, Inc. | EBF |
| Sep 13, 1993 | K932793 | PULPDENT 2.5% NITRIC ACID ETCHANT Pulpdent Corp. | EBF |
| Sep 13, 1993 | K932227 | AMELOGEN RESTORATIVE MATERIALS Ultradent Products, Inc. | EBF |
| Sep 9, 1993 | K932792 | PULPDENT MALEIC ACID ETCHANTS Pulpdent Corp. | EBF |
| Sep 9, 1993 | K931867 | ULTRA-ETCH ENAMEL PREPARATION PRODUCT LINE Ultradent Products, Inc. | EBF |
| Aug 25, 1993 | K932395 | VLC DR MATERIAL Dentsply Intl. | EBF |
| Aug 24, 1993 | K930405 | BISCO D/C CORE COMPOSITE Bisco, Inc. | EBF |
| Jul 22, 1993 | K931309 | VARIOLINK Ivoclar North America, Inc. | EBF |
| Jul 8, 1993 | K932013 | CHARISMA -- MODIFIED Heraeus Kulzer, Inc. | EBF |
| Jul 8, 1993 | K931880 | PROFILL LC COMPOSITE Jedental Co., Inc. | EBF |
| Jun 17, 1993 | K924727 | 100 LIGHT CURE UNIT Rolence Enterprise Co. , Ltd., TW | EBF |
| May 19, 1993 | K920533 | DENTIN BONDING AGENT Confi-Dental Products Co. | EBF |
| Apr 23, 1993 | K926556 | VIVALUX Ivoclar North America, Inc. | EBF |
| Mar 31, 1993 | K926418 | CLIP Voco GmbH | EBF |
| Mar 16, 1993 | K926074 | PULPDENT DENTAL BOND ENCHANCER Pulpdent Corp. | EBF |
| Mar 16, 1993 | K925162 | MICRODOSE DENTIN CONDITIONER Unicep | EBF |
| Mar 5, 1993 | K924826 | MICRODOSE TOTAL ETCHANT Unicep | EBF |
| Mar 5, 1993 | K924822 | MICRODOSE ENAMEL ETCHANT Unicep | EBF |
| Jan 28, 1993 | K925383 | PHOTO CLEARFIL OPAQUER Kuraray Co. | EBF |
| Dec 28, 1992 | K924151 | BISCO D/C RESINOMER Bisco, Inc. | EBF |
| Oct 13, 1992 | K923472 | COMPACOLOR Wilde-USA, Inc. | EBF |
| Oct 6, 1992 | K923867 | METAFIL Parkell | EBF |
| Sep 11, 1992 | K923236 | TRIAD INLAY COMPOSITE Dentsply Intl. | EBF |
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