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 24, 2004 | K033996 | HERMES 3M Espe AG Dental Products, DE | EBF |
| Feb 2, 2004 | K033808 | GRADIA GUM GC America, Inc. | EBF |
| Jan 15, 2004 | K033773 | CONCEPT HP ADD-ON; CONCEPT HP ENAMEL Ivoclar Vivadent, AG | EBF |
| Dec 30, 2003 | K033665 | VENUS FLOW Heraeus Kulzer, Inc. | EBF |
| Dec 22, 2003 | K033267 | EPRICORD Kuraray Medical, Inc. | EBF |
| Nov 25, 2003 | K033117 | GRANDIO FLOW Voco GmbH | EBF |
| Nov 13, 2003 | K032921 | PREMISE Sybron Dental Specialties, Inc. | EBF |
| Oct 29, 2003 | K031341 | STICK FLOW Stick Tech , Ltd. | EBF |
| Sep 11, 2003 | K031721 | COMPOSITE RESTORATION MATERIAL Milton Hodosh, M.D. | EBF |
| Aug 1, 2003 | K031877 | EMBRACE WET-BOND RESTORATIVE MATERIAL Pulpdent Corporation | EBF |
| Jun 6, 2003 | K030951 | TESCERAFLO A2, MODEL T-21012P; TESCERAFLO A2 OPAQUE, MODEL T-210120P Bisco, Inc. | EBF |
| May 30, 2003 | K030915 | GRANDIO Voco GmbH, DE | EBF |
| May 30, 2003 | K030914 | REBILDA DC Voco GmbH, DE | EBF |
| Apr 29, 2003 | K030133 | SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE Dentalez Group | EBF |
| Feb 14, 2003 | K024094 | 4 SEASONS Ivoclar Vivadent, Inc. | EBF |
| Jan 30, 2003 | K023814 | GRADIA DIRECT GC America, Inc. | EBF |
| Jan 17, 2003 | K023742 | SCULPTURE PLUS NANO-HYBRID COMPOSITE Pentron Laboratory Technologies | EBF |
| Nov 25, 2002 | K022971 | MICROHYBRID 11 Ab Ardent | EBF |
| Nov 22, 2002 | K022975 | ETCHING 15 Ab Ardent | EBF |
| Nov 22, 2002 | K022974 | MICROHYBRID 12 Ab Ardent | EBF |
| Nov 22, 2002 | K022972 | MICROFILL 13 Ab Ardent | EBF |
| Nov 7, 2002 | K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL Prime Dental Manufacturing, Inc. | EBF |
| Oct 25, 2002 | K023002 | CLEARFIL AP-X PLT Kuraray Medical, Inc. | EBF |
| Oct 24, 2002 | K022999 | CLEARFIL AP-X PLT INTRO KIT Kuraray Medical, Inc. | EBF |
| Oct 24, 2002 | K021250 | MK-DENT PUSH BUTTON HIGHSPEED HANDPIECE, 4 HOLES, MODELS HS 2012 (STANDARD HEAD) & HS 2014 (SMALL HEAD) Handpiece Unlimited, DE | EBF |
| Oct 11, 2002 | K022492 | PULPDENT SEMI-GEL ETCH Pulpdent Corporation | EBF |
| Oct 10, 2002 | K022797 | TWINKY STAR Voco GmbH | EBF |
| May 17, 2002 | K020113 | VECTOR F SERIES HIGH-SPEED DENTAL HANDPIECES Vector Research & Development | EBF |
| May 3, 2002 | K020760 | STARFLOW HV Danville Materials, Inc. | EBF |
| Apr 22, 2002 | K020555 | SONATA MICRO HYBRID COMPOSITE Pentron Laboratory Technologies | EBF |
| Apr 17, 2002 | K020432 | PULPDENT GLAZE Pulpdent Corporation | EBF |
| Mar 28, 2002 | K020342 | UNIFIL FLOW GC America, Inc. | EBF |
| Mar 6, 2002 | K014111 | REBILDA SC Voco GmbH | EBF |
| Feb 28, 2002 | K020131 | VENUS UNIVERSAL LIGHT CURING COMPOSITE Heraeus Kulzer, Inc. | EBF |
| Feb 19, 2002 | K013970 | PRIME-DENT HEMA DESENSITIZER Prime Dental Manufacturing, Inc. | EBF |
| Feb 7, 2002 | K014144 | EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 Afp Imaging Corp. | EBF |
| Feb 7, 2002 | K013929 | HELIOMOLAR HB TRANSLUCENT SHADES Ivoclar Vivadent, Inc. | EBF |
| Jan 18, 2002 | K013510 | POINT 4 MODIFIED Sybron Dental Specialties, Inc. | EBF |
| Jan 17, 2002 | K013571 | MAGICFIL Dmg USA, Inc. | EBF |
| Jan 17, 2002 | K011839 | DOXADENT DENTAL COMPOSITE, MODELS A, B, C, 12A, 12B, 12C, 6A, 6B, AND 6C Doxa Certex AB | EBF |
| Jan 16, 2002 | K013647 | REVOLUTION FORMULA 2 Sybron Dental Specialties, Inc. | EBF |
| Jan 9, 2002 | K013529 | POINT 4 TRANSLUCENT MODIFIED Sybron Dental Specialties, Inc. | EBF |
| Dec 10, 2001 | K013400 | SYNERGY FLOW Coltene/Whaledent, Inc. | EBF |
| Nov 5, 2001 | K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT Prime Dental Manufacturing, Inc. | EBF |
| Oct 29, 2001 | K013375 | BELLEGLASS HP OPAQUE 2 Kerr Dental Materials Center | EBF |
| Oct 23, 2001 | K013325 | POINT 4 FLOWABLE 2 Kerr Dental Materials Center | EBF |
| Oct 22, 2001 | K012529 | ROK Southern Dental Industries, Ltd. | EBF |
| Oct 22, 2001 | K012528 | ICE Southern Dental Industries, Ltd. | EBF |
| Oct 3, 2001 | K013009 | BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 Sybron Dental Specialties, Inc. | EBF |
| Oct 1, 2001 | K013007 | BELLEGLASS HP ENAMEL 2 Sybron Dental Specialties, Inc. | EBF |
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