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 22, 1986 | K862449 | DEN-MAT DENTIN LINK Den-Mat Corp. | EBF |
| Jul 18, 1986 | K862648 | V-BOND, PAINT-ON COMPOSITE RESTOR/VENEER CEMENT Scientific Pharmaceuticals, Inc. | EBF |
| Jul 9, 1986 | K861833 | RESTOR (COMET)*DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Jun 25, 1986 | K861899 | SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE 3M Company | EBF |
| May 30, 1986 | K860487 | URENAMEL, POSTERIOR RESTORATIVE MATERIAL Cadco Dental Products, Inc. | EBF |
| May 21, 1986 | K861740 | P-50 LIGHT CURED RESIN BONDED CERAMIC 3M Company | EBF |
| May 21, 1986 | K861546 | REPLICA-F VISIBLE LIGHT-CURED ANT/POST DEN COM KIT Macrochem Corp. | EBF |
| Apr 30, 1986 | K861148 | BISCO'S PORCELAIN VENEER SYSTEM Bisco, Inc. | EBF |
| Apr 17, 1986 | K860708 | PHOTO CLEARFIL OPAQUER Kuraray Co. | EBF |
| Apr 8, 1986 | K860626 | NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID Scientific Pharmaceuticals, Inc. | EBF |
| Mar 26, 1986 | K860627 | SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE Scientific Pharmaceuticals, Inc. | EBF |
| Mar 13, 1986 | K854755 | RENAMEL ESTHETIC RESTORATIVE SYSTEM Cosmedent, Inc. | EBF |
| Mar 4, 1986 | K854803 | CHAMELEON BONDING KIT Pentron Corp. | EBF |
| Nov 19, 1985 | K853055 | LIGHT CURE FILLING MATERIAL Foremost Dental Mfg., Inc. | EBF |
| Oct 31, 1985 | K853431 | DENTAL CEMENT Dentsply Intl. | EBF |
| Sep 27, 1985 | K852868 | WUNDERSHADE Harry J. Bosworth Co. | EBF |
| Aug 16, 1985 | K853002 | BISFIL-II(CHEMICAL CURABLE POSTERIOR/ANTERIOR) Bisco, Inc. | EBF |
| Aug 16, 1985 | K853001 | BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE) Bisco, Inc. | EBF |
| Aug 16, 1985 | K852745 | PORCELAIN VENEER SYSTEM BONDING KIT The S. S. White Co. | EBF |
| Aug 16, 1985 | K852744 | CHARACTERIZER KIT VISIBLE LIGHT CURED RESTOR-COLOR The S. S. White Co. | EBF |
| Jul 31, 1985 | K851929 | RESTORE* Johnson & Johnson Professionals, Inc. | EBF |
| Jul 30, 1985 | K852659 | BIOGLOSS Dentsply Intl. | EBF |
| Jul 24, 1985 | K852658 | ETEN-GEL Dentsply Intl. | EBF |
| Jul 1, 1985 | K852344 | DISTALITE POSTERIA DENTAL RESTORATIVE Johnson & Johnson Professionals, Inc. | EBF |
| Jul 1, 1985 | K852151 | PHOTO CURING LIGHT Dentsply Intl. | EBF |
| May 21, 1985 | K851459 | VISILUX 2 VISIBLE LIGHT CURING UNIT 3M Company | EBF |
| Apr 22, 1985 | K850965 | KULZER DENTIN ADHESIVE Kulzer, Inc. | EBF |
| Apr 16, 1985 | K850911 | TRIAD C & B MATERIAL Dentsply Intl. | EBF |
| Apr 8, 1985 | K850824 | PHOTO CLEARFIL A. A LIGHT CURED ADHES. DENTAL REST Kuraray Co. | EBF |
| Mar 25, 1985 | K844662 | KERR HERCULITE DENTAL COMPOSITE RESTORATIVE MATERI Kerr Corporation (Danbury) | EBF |
| Mar 18, 1985 | K845033 | FOREMOST DENTIN ADHESIVE Foremost Dental Mfg., Inc. | EBF |
| Dec 3, 1984 | K844326 | OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITE Coe Laboratories, Inc. | EBF |
| Oct 25, 1984 | K843363 | RESTODENT VL Lee Pharmaceuticals | EBF |
| Sep 27, 1984 | K843026 | KERR GELLED PHOSPHORIC ACID ETCHANT Kerr Corporation (Danbury) | EBF |
| Sep 7, 1984 | K843072 | EVER-BOND V GLASS LONOMER RESTORATIVE Kerr Corporation (Danbury) | EBF |
| Jul 12, 1984 | K842087 | BISFIL-I LIGHT CURABLE POSTERIOR COMPO Bisco, Inc. | EBF |
| Jun 22, 1984 | K841550 | SCOTCHBOND LIGHT CURED DENTAL ADHES 3M Company | EBF |
| May 22, 1984 | K841667 | WUNDERFIL Harry J. Bosworth Co. | EBF |
| May 22, 1984 | K841269 | C-19 Pentron Corp. | EBF |
| May 22, 1984 | K841268 | C-17 Pentron Corp. | EBF |
| May 21, 1984 | K841518 | JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II) Johnson & Johnson Professionals, Inc. | EBF |
| Apr 30, 1984 | K841267 | C-18 Pentron Corp. | EBF |
| Apr 25, 1984 | K833797 | LIGHT CURED RESIN BONDED CERAMIC 3M Company | EBF |
| Apr 13, 1984 | K840727 | PENTRA-FIL II Pentron Corp. | EBF |
| Apr 13, 1984 | K840176 | ESTIC MICROFILL Kulzer, Inc. | EBF |
| Mar 30, 1984 | K841111 | REMBRANDT SHADE MODIFICATION KIT Den-Mat Corp. | EBF |
| Mar 30, 1984 | K840084 | COLTENE BRILLIANT LUX Bauer, Cheng & Associates, Inc. | EBF |
| Mar 30, 1984 | K833725 | PRE-LOADED C-R TUBES FOR SYRINGE Centrix, Inc. | EBF |
| Mar 16, 1984 | K840085 | COLTENE BRILLIANT Bauer, Cheng & Associates, Inc. | EBF |
| Feb 21, 1984 | K833810 | CURAY-MATCH PAINT-ON COMPOSITE RESTOR Scientific Pharmaceuticals, Inc. | EBF |
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