Powder, Porcelain
Regulation 872.6660
17510(k)s in 12 months (491 all time)
1recalls in 12 months (35 all time)
35recalls that name a 510(k)
Top companies in EIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Ivoclar Vivadent, AG | 9 | 32 |
| Dentsply Intl. | 23 | 0 |
| Prismatik Dentalcraft, Inc. | 21 | 1 |
| Vident | 16 | 0 |
| Shofu Dental Corp. | 15 | 0 |
| Noritake Co., Inc. | 14 | 0 |
| Wieland Dental + Technik GmbH & Co. KG | 14 | 0 |
| Jensen Industries, Inc. | 11 | 0 |
| Kuraray Noritake Dental, Inc. | 11 | 0 |
| Genoss | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 26, 2015 | K150196 | DD cubeX2 Dental Direkt GmbH, DE | EIH |
| Feb 27, 2015 | K143439 | KATANA Zirconia Kuraray Noritake Dental, Inc., JP | EIH |
| Feb 11, 2015 | K142987 | DD Bio Z, DD Bio ZX(square), DD BioZX(square) color Dental Direkt of Amerika UG (Haftungsbeschraenkt), DE | EIH |
| Jan 28, 2015 | K141400 | DCCERAM SYSTEM Ceramay GmbH & Co.Kg | EIH |
| Jan 5, 2015 | K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Dec 18, 2014 | K142043 | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA Jensen Industries, Inc. | EIH |
| Dec 18, 2014 | K141727 | DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) Liaoning Upcera Co., Ltd. | EIH |
| Dec 17, 2014 | K140848 | LUMINESSE PORCELAIN SYSTEM Talladium, Inc. | EIH |
| Dec 15, 2014 | K143330 | BruxZir Anterior Prismatik Dentalcraft, Inc. | EIH |
| Nov 6, 2014 | K141887 | OBSIDIAN PRESS (ALL CERAMIC AND POM) Prismatik Dentalcraft, Inc. | EIH |
| Nov 5, 2014 | K132230 | ICE ZIRKON TRANSLUZENT Zirkonzahn Srl | EIH |
| Oct 22, 2014 | K142670 | Vericore Zirconia Blanks Whip Mix Corporation | EIH |
| Oct 22, 2014 | K141724 | UPCERA DENTAL ZIRCONIA BLANK & DENTAL ZIRCONIA PRE-SHADED BLANK Liaoning Upcera Co., Ltd. | EIH |
| Oct 22, 2014 | K141723 | UPCERA COLORING LIQUID (I AND II ) Liaoning Upcera Co., Ltd. | EIH |
| Oct 9, 2014 | K141659 | PRISM ZIRCONIA, ST-98 A & D Dental Innovations | EIH |
| Sep 3, 2014 | K140877 | VERICORE ZIRCONIA BLANKS Whip Mix Corp. | EIH |
| Aug 27, 2014 | K141162 | ALL-CERAMIC ZIRCONIA BLOCK Rizhao Huge Dental Industry Co., Ltd., CN | EIH |
| Aug 20, 2014 | K141788 | OBSIDIAN MILLING BLOCKS Prismatik Dentalcraft, Inc. | EIH |
| Jun 5, 2014 | K140924 | STARCERAM H.C. Starck Ceramics GmbH | EIH |
| May 7, 2014 | K140070 | LUXER SHADED ZIRCONIA Continental Dental Ceramics, Inc. | EIH |
| Mar 20, 2014 | K133211 | ZIRTOUGH Kuraray Noritake Dental, Inc. | EIH |
| Feb 10, 2014 | K130991 | NEXXZR(TM)T AND NEXXZR(TM)S Sagemax Bioceramics, Inc. | EIH |
| Jan 31, 2014 | K132070 | VITA SUPRINITY(R) Vita Zahnfabrik H.Rauter GmbH & Co. | EIH |
| Dec 5, 2013 | K133213 | STARCERAM H.C. Starck Ceramics GmbH | EIH |
| Nov 12, 2013 | K132102 | BECE CAD ZIRKON HT+ Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO, DE | EIH |
| Oct 21, 2013 | K130198 | NEO DENTA ZIRCONIA Neo Group Limited, HK | EIH |
| Oct 11, 2013 | K131534 | KATANA ZIRCONIA Kuraray Noritake Dental, Inc. | EIH |
| Sep 24, 2013 | K130654 | CRYSTAL ULTRA Dental Laboratory Milling Supplies, LLC (Dlms) | EIH |
| Sep 12, 2013 | K130604 | UNIVERSAL PASTE STAINS AND GLAZE Prismatik Dentalcraft, Inc. | EIH |
| Jul 26, 2013 | K131117 | ZIRMON SERIES Kuwotech Co., Ltd. | EIH |
| May 24, 2013 | K130184 | ZENOLUX Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| May 16, 2013 | K130924 | BRUXZIR SHADED Prismatik Dentalcraft, Inc. | EIH |
| May 16, 2013 | K122614 | VINTAGE MP PRESS OVER Shofu Dental Corporation | EIH |
| Apr 8, 2013 | K123664 | INCORIS ZI Sirona Dental Systems GmbH, DE | EIH |
| Mar 20, 2013 | K123952 | CEREC BLOCS C IN Sirona Dental Systems GmbH, DE | EIH |
| Feb 22, 2013 | K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC Dentsply Intl. | EIH |
| Feb 21, 2013 | K123680 | COPRANCOLOR White Peaks Dental Systems GmbH & Co. KG, DE | EIH |
| Feb 20, 2013 | K123613 | SYNSPAR ADVANCED Ardent, Inc. | EIH |
| Feb 1, 2013 | K123545 | INCORIS TZI Sirona Dental Systems GmbH, DE | EIH |
| Dec 13, 2012 | K122269 | ENAMIC Vita Zahnfabrik H.Rauter GmbH & Co. | EIH |
| Oct 24, 2012 | K122972 | CDC ZIRCONIA BLANKS Continental Dental Ceramics, Inc. (Dba Continental | EIH |
| Oct 19, 2012 | K121980 | ZIRPRIME Kuraray Noritake Dental, Inc. | EIH |
| Jul 27, 2012 | K121359 | IPS 99 ONE AND IPS 99 CERAM Ivoclar Vivadent, AG | EIH |
| Jun 25, 2012 | K120134 | IPS E.MAX PRESS MULTI Ivoclar Vivadent, AG | EIH |
| Jun 6, 2012 | K120852 | ZIRCONIA BLANKS (ZIRCOSTAR) Kerox, Ltd. | EIH |
| Mar 30, 2012 | K113431 | CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA Bettini S.P.A. | EIH |
| Mar 7, 2012 | K113575 | HILLA DIGITAL TRANSFERS Hilla Technologies, Inc. | EIH |
| Jan 13, 2012 | K120011 | HEISENBERG EFFECT SHADES 3M Espe AG, DE | EIH |
| Dec 1, 2011 | K112806 | JENSEN ZIRCONIA Jensen Industries, Inc. | EIH |
| Nov 9, 2011 | K112152 | CERCON HT Dentsply International, Inc. | EIH |
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