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 |
|---|---|---|---|
| Oct 17, 2011 | K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Sep 14, 2011 | K111743 | THE INSYNC CERAMIC SYSTEM Jensen Industries, Inc. | EIH |
| Aug 26, 2011 | K111573 | MONOBLOC BM SERIES Hass Corp. | EIH |
| Aug 12, 2011 | K111383 | ZIRPRIME Noritake Co., Inc. | EIH |
| Aug 11, 2011 | K110719 | ORIGIN ZIRCONIA B&D Dental Technologies | EIH |
| Jul 20, 2011 | K111291 | AIDITE ZIRCONIA DENTAL CERAMICS Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | EIH |
| Jun 30, 2011 | K111107 | SUPER PORCELAIN EX-3 UNIVERSAL OPAQUE Noritake Co., Inc. | EIH |
| May 13, 2011 | K111257 | HEISENBERG DYEING LIQUIDS 3M Espe AG, DE | EIH |
| Apr 13, 2011 | K103556 | IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE) Ivoclar Vivadent, Inc. | EIH |
| Mar 16, 2011 | K103773 | ZENOFLEX DIMENSION Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Feb 16, 2011 | K103494 | ZENOSTAR MAGIC GLAZE Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Jan 25, 2011 | K100794 | FLUORCANASITE DENTAL CERAMIC Dr Sarah Pollington | EIH |
| Dec 3, 2010 | K102305 | HASS ZIRTOOTH MODEL ZORTOOTH H. ZIRTOOTH T. ZIRTOOTHC, ZIRTOOTH P Hass Corp. | EIH |
| Oct 27, 2010 | K102538 | ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI Jyoti Ceramic Industries Private Limited, IN | EIH |
| Aug 23, 2010 | K101875 | BK BLANK MODEL 20,40,65,90 Bk Medent Co., Ltd. | EIH |
| Aug 20, 2010 | K100512 | NOBELPROCERA IPS E.MAX CROWN Nobel Biocare AB | EIH |
| Aug 11, 2010 | K102128 | VITABLOCS Vita Zahnfabrik H.Rauter GmbH & Co. | EIH |
| Jun 21, 2010 | K100781 | OBSIDIAN CERAMIC BLOCKS Prismatik Dentalcraft, Inc. | EIH |
| May 25, 2010 | K100150 | CERAMICS2IN1 Biodenta Swiss AG, CH | EIH |
| May 21, 2010 | K100232 | LUMINESSE ZR BLANKS Talladium, Inc. | EIH |
| Apr 13, 2010 | K100145 | A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 A&E Bioceramic Co., Ltd., TW | EIH |
| Apr 8, 2010 | K100250 | XCERAM Xceramusa | EIH |
| Mar 12, 2010 | K093571 | ZR DENTAL BLOCK Ams Co., Ltd., KR | EIH |
| Mar 3, 2010 | K093559 | VINTAGE MP Shofu Dental Corp. | EIH |
| Feb 24, 2010 | K093748 | DD BIO Z AND DD BIO Z - TRANSPA Dental Direkt of Amerika UG (Haftungsbeschraenkt), DE | EIH |
| Jan 28, 2010 | K093560 | UPCERA ZIRCONIA BLANKS Shenyang Upcera Co., Ltd. | EIH |
| Dec 3, 2009 | K093446 | VITA VMK MASTER Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | EIH |
| Oct 22, 2009 | K092630 | ZIROX Zencera, Inc., KR | EIH |
| Oct 9, 2009 | K092513 | RAINBOW BLOCK Genoss Co., Ltd. | EIH |
| Sep 29, 2009 | K092020 | AADVA ZR COLORING LIQUID GC America, Inc. | EIH |
| Sep 25, 2009 | K091826 | ELEGANT 3M Espe AG Dental Products, DE | EIH |
| Sep 21, 2009 | K090718 | BELLUS SHADING KIT 3M Espe AG Dental Products, DE | EIH |
| Sep 18, 2009 | K092496 | COPRAN ZR/ORIGIN YZ White Peaks Dental Systems GmbH & Co. KG, DE | EIH |
| Sep 10, 2009 | K091852 | BISQUE ZIRCONIA BLANKS, MODEL R610191, R610210, R610211, R610205 Refractron Technologies Corp. | EIH |
| Aug 28, 2009 | K091706 | QUATTRO PORCELAIN SYSTEM Dentsply International, Inc. | EIH |
| Jul 6, 2009 | K090434 | BECE PRESS Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO, DE | EIH |
| Jun 18, 2009 | K091096 | NATURAZ SERIES, MODEL B16,B20, B42, B60, B98, B100 Dental Solutions, Inc. | EIH |
| May 1, 2009 | K090684 | AVANTE LEUCITE BLOCKS Somerset Dental Products, Inc. | EIH |
| Mar 31, 2009 | K090644 | VITABLOCS, MODEL VX55-**** Vita Zahnfabrik H.Rauter GmbH & Co. | EIH |
| Feb 10, 2009 | K082137 | DLMS-ZIRBLOCKS Dental Milling Laboratory Supplies (Dlms) | EIH |
| Jan 26, 2009 | K083201 | ZMATCH BLOCK Dentaim Co., Ltd., KR | EIH |
| Dec 30, 2008 | K082652 | BITTAR ZIRCONIA BLOCKS Bittar Zirconia Block, LLC | EIH |
| Nov 26, 2008 | K082740 | GC AADVA ZR DISK GC America, Inc. | EIH |
| Oct 15, 2008 | K082158 | DENSEO FAIRY Xpdent Corp | EIH |
| Sep 30, 2008 | K081749 | AVANTE Z ZIRCONIA (AS)3 BLOCKS Pentron Ceramics, Inc. | EIH |
| Sep 25, 2008 | K081850 | BISQUE ZIRCONIA BLANKS, TYPE BYZ Zircar Zirconia, Inc. | EIH |
| Sep 18, 2008 | K082257 | ZENO AI ECO DISC Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Aug 8, 2008 | K081200 | DENTAL PORCELAIN (GLASS POWDER), TOP-CERAM T-1, T1, T2, T3, T4 Global Top, Inc., KR | EIH |
| Jul 1, 2008 | K081263 | STARCERAM H.C. Starck Ceramics GmbH & Co.Kg | EIH |
| Jun 11, 2008 | K080834 | VINTAGE ART Shofu Dental Corp. | EIH |
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