Material, Tooth Shade, Resin
Regulation 872.3690
19510(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 |
|---|---|---|---|
| Jan 11, 2017 | K162261 | CERAMAGE UP Shofu Dental Corporation | EBF |
| Nov 28, 2016 | K163207 | Filtek One Bulk Fill Restorative 3M Company | EBF |
| Nov 16, 2016 | K162537 | CAD/CAMouflage Milling Block Prismatik Dentalcraft, Inc. | EBF |
| Nov 15, 2016 | K160049 | Charisma Heraeus Kulzer, LLC (Mitsui Chemicals Group) | EBF |
| Nov 7, 2016 | K162257 | P1145 Dental Restorative Kerr Corporation | EBF |
| Oct 24, 2016 | K151399 | Capo Hybrid, Capo Slow Flow, Capo Flow, Capo Natural, Capo Universal, Nano Paq, Nano Paq Flow Schutz Dental GmbH, DE | EBF |
| Sep 27, 2016 | K162107 | TPH Spectra+ Universal Composite Restorative Dentsply Sirona | EBF |
| Aug 23, 2016 | K153476 | KATANA AVENCIA Block Kuraray Noritake Dental, Inc., JP | EBF |
| Aug 4, 2016 | K152471 | CAPO BULK FILL Schuetz Dental GmbH, DE | EBF |
| Jul 29, 2016 | K153493 | Clip Flow Voco GmbH, DE | EBF |
| Jul 27, 2016 | K160596 | BEAUTIFIL II LS Shofu Dental Corporation | EBF |
| Jul 21, 2016 | K160086 | SHOFU Enamel Conditioner Shofu Dental Corporation | EBF |
| Jul 21, 2016 | K152113 | BioHPP - breCAM.BioHPP Bredent GmbH & Co. KG, DE | EBF |
| Jul 15, 2016 | K160425 | CAD/CAMouflage Milling Bock Prismatik Dentalcraft, Inc. | EBF |
| Jul 12, 2016 | K153325 | Gradia Plus GC America, Inc. | EBF |
| Jun 30, 2016 | K153177 | Admira Fusion Flow Voco GmbH, DE | EBF |
| May 20, 2016 | K153127 | everX Posterior GC America, Inc. | EBF |
| Apr 28, 2016 | K152927 | BRILLIANT EVERGLOW Coltene/Whaledent AG, CH | EBF |
| Apr 1, 2016 | K153249 | Pulpdent Solo Flowable Composite with MCP Pulpdent Corporation | EBF |
| Mar 2, 2016 | K151700 | BEAUTIFIL II Gingiva Shofu Dental Corporation | EBF |
| Feb 26, 2016 | K153191 | Calcium Bridge Denali Corporation | EBF |
| Dec 30, 2015 | K152373 | VITA VM LC Flow Vita Zahnfabrik H.Rauter GmbH & Co., DE | EBF |
| Dec 10, 2015 | K151699 | BEAUTIFIL II Enamel Shofu Dental Corporation | EBF |
| Nov 17, 2015 | K152004 | Nanova Universal Composite Nanova Biomaterials, Inc. | EBF |
| Oct 20, 2015 | K151956 | Admira Fusion x-tra Voco GmbH, DE | EBF |
| Oct 9, 2015 | K151541 | G-Fix GC America, Inc. | EBF |
| Sep 21, 2015 | K151514 | Prestige Danville Materials, LLC | EBF |
| Aug 28, 2015 | K151088 | DMRC Bulk Fill Danville Materials, LLC | EBF |
| Jul 21, 2015 | K151094 | Mosaic Universal Composite Ultradent Products, Inc. | EBF |
| Jul 2, 2015 | K150784 | Admira Fusion Voco GmbH, DE | EBF |
| Jun 23, 2015 | K150218 | Fill-Up! Coltene/Whaledent AG, CH | EBF |
| Jun 18, 2015 | K150623 | Nanova Flowable Composite Nanova Biomaterials, Inc. | EBF |
| Jun 9, 2015 | K150393 | TETRIC EVOFLOW BULK FILL Ivoclar Vivadent, AG, LI | EBF |
| Jun 2, 2015 | K143524 | Fiber Disks and Blocks (TRINIA) Bicon, LLC | EBF |
| May 15, 2015 | K143694 | Rhondium One-Visit-Crown(OVC) Rhondium, Ltd., NZ | EBF |
| May 1, 2015 | K143679 | Nuance FLOW Den-Mat Holdings, LLC | EBF |
| Mar 25, 2015 | K143104 | Visalys Core, Visalys PL-Core, Visalys PL-Core-C, Visalys PL-Core-X Kettenbach GmbH & Co. KG, DE | EBF |
| Feb 5, 2015 | K143209 | SonicFill 2 Sybron Dental Specialties | EBF |
| Nov 25, 2014 | K142389 | Variolink Esthetic Ivoclar Vivadent, AG, LI | EBF |
| Nov 14, 2014 | K141994 | BULK FILL FLOWABLE COMPOSITE Novocol, Inc. | EBF |
| Jul 10, 2014 | K140976 | ENADEN FLOW Km Corporation | EBF |
| Jul 2, 2014 | K140512 | UFILL BULK FILL POSTERIOR FLOWABLE COMPOSITE Juno Dentistry LP | EBF |
| Jun 25, 2014 | K132115 | ABSOLUTE DENTIN 2 Parkell, Inc. | EBF |
| Jun 4, 2014 | K133850 | CAMOUFLAGE NANOHYBRID COMPOSITE (UNIVERSAL & FLOWABLE) Prismatik Dentalcraft, Inc. | EBF |
| May 8, 2014 | K141081 | FILTEK BULK FILL POSTERIOR RESTROATIVE 3M Espe Dental Products | EBF |
| Apr 9, 2014 | K133182 | HTFX-222 GC America, Inc. | EBF |
| Mar 14, 2014 | K133824 | CERASMART GC America, Inc. | EBF |
| Mar 14, 2014 | K133608 | TRINIA Bicon, LLC | EBF |
| Dec 4, 2013 | K132748 | BEAUTIFIL E POSTERIOR, BEAUTIFIL BULK Shofu Dental Corporation | EBF |
| Nov 14, 2013 | K131753 | MERIDIAN Ab Ardent | EBF |
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