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 |
|---|---|---|---|
| Jun 6, 2008 | K080146 | ZIRKONDENT Ergometa | EIH |
| May 21, 2008 | K080479 | DENTAL CERAMIC Dmg USA, Inc. | EIH |
| May 15, 2008 | K081253 | ZIRDENT CAD/CAM BLOCKS C5 Medical Werks, Inc. | EIH |
| Apr 28, 2008 | K080195 | NACERA Z AND NACERA Z MEDIUM Doceram Medical Ceramics GmbH, DE | EIH |
| Feb 21, 2008 | K073314 | HEANY INDUSTRIES INC DENTAL XIRCONIA Heany Industries, Inc. | EIH |
| Feb 6, 2008 | K073568 | PSL BIOZIR BLOCK P.S.L. International, Inc., CA | EIH |
| Nov 21, 2007 | K073108 | ZENO ZR DISC Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Oct 31, 2007 | K072569 | METOXIT CAM-BLANKS Metoxit AG | EIH |
| Aug 30, 2007 | K071848 | IPS INLINE POM SYSTEM Ivoclar Vivadent, Inc. | EIH |
| Aug 24, 2007 | K071010 | TIZIAN CERAMIC, FLOW, PLATE, FIX & ZR BLANKS Schutz-Dental GmbH, DE | EIH |
| Aug 15, 2007 | K071410 | ARGEN PEARL BRAND ZIRCONIA The Argen Corporation | EIH |
| Aug 9, 2007 | K071674 | GC-ZIRCONIA GC America, Inc. | EIH |
| Jul 30, 2007 | K071201 | ZEO CE LIGHT & ZEO QUICK PORCELAIN Xpdent Corp | EIH |
| Jun 29, 2007 | K070699 | AVANTE Z; PELLET, PRESSABLE STAIN, ADD-ON PORCELAIN, PORCELAIN Pentron Ceramics, Inc. | EIH |
| Apr 30, 2007 | K070772 | PRESSX ZR Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Apr 30, 2007 | K070537 | ZIRBLOCK Cdl Technologies, Inc. | EIH |
| Apr 17, 2007 | K063842 | CYRTINA SYSTEM Oratio B.V., NL | EIH |
| Mar 26, 2007 | K070045 | ZIRBLANK-PS AND ZIRBLANK-FS Acucera, Inc., KR | EIH |
| Mar 1, 2007 | K070114 | CREATION CP-ZI PORCELAIN Jensen Industries, Inc. | EIH |
| Feb 2, 2007 | K063511 | CERAMILL ZI Amann Girrbach America, Inc. | EIH |
| Jan 26, 2007 | K070019 | CARRARA VOLUMIA Dentsply Intl. | EIH |
| Oct 20, 2006 | K062695 | SAGEMAX Z-BLANK Sagemax Bioceramics, Inc. | EIH |
| Oct 6, 2006 | K061804 | ZERION ALPHA, ; ZERION BETA Etkon International GmbH, DE | EIH |
| Sep 29, 2006 | K061851 | ZIRKONZAHN ICE Zirkonzahn GmbH | EIH |
| Sep 12, 2006 | K062509 | INCORIS ZI Sirona Dental Systems GmbH, DE | EIH |
| Sep 8, 2006 | K062506 | INCORIS AL Sirona Dental Systems GmbH, DE | EIH |
| Sep 5, 2006 | K062504 | CERAMAX Alphadent Co., Ltd., KR | EIH |
| Aug 21, 2006 | K062389 | Z-BLOCK, MODELS 20/19, 40/19, 55/19 Foundation Milling Centre | EIH |
| May 19, 2006 | K060860 | TURKOM-CERA Dental Suppliers of America, Inc. | EIH |
| Apr 27, 2006 | K060441 | VITA VM 7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, MODEL NX98 Vident | EIH |
| Mar 15, 2006 | K060104 | PRISMATIK CLINICAL ZIRCONIA Glidewell Laboratories | EIH |
| Mar 3, 2006 | K060086 | FENIIIIIIX COLORATION KIT Dental Arte, Inc. | EIH |
| Jan 18, 2006 | K053438 | GLASS CERAMICS 3M Espe AG Dental Products, DE | EIH |
| Jan 13, 2006 | K052710 | VITA VM7, MODEL NX77 XXXX, NX78XXXX, NX79 XXXX; VITA VM 8, MODEL VX60 XXXX, VX61 XXXX, VX62 XXXX; VITA VM 9, Vident | EIH |
| Nov 23, 2005 | K052304 | SUPER PORCELAIN EX-3 PRESS Noritake Co., Inc. | EIH |
| Nov 18, 2005 | K052033 | VINTAGE ZR Shofu Dental Corp. | EIH |
| Oct 25, 2005 | K052543 | HERACERAM ZIRKONIA Heraeus Kulzer, Inc. | EIH |
| Oct 14, 2005 | K051705 | IPS E.MAX CAD/IPS E.MAX ZIRCAD Ivoclar Vivadent, Inc. | EIH |
| Aug 15, 2005 | K052130 | VITA IN-CERAM 2000 AL CUBES FOR INLAB, MODELS AL20/AL40 Vident | EIH |
| Jul 22, 2005 | K051249 | ZIROX Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Jun 24, 2005 | K051462 | MODIFICATION TO: CERCON BASE Dentsply Intl. | EIH |
| Jun 23, 2005 | K050903 | XAWEX G 100 Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| May 11, 2005 | K050920 | CZR PRESS LF STAINS Noritake Co., Inc. | EIH |
| May 4, 2005 | K050838 | THE LF-P CERAMIC SYSTEM Jensen Industries, Inc. | EIH |
| Mar 15, 2005 | K050362 | VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) Vident | EIH |
| Mar 3, 2005 | K050144 | PRISMATIK CERAMIC Glidewell Laboratories | EIH |
| Feb 14, 2005 | K050203 | ALLUX Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Feb 7, 2005 | K050160 | KATANA ZIRCONIA Noritake Co., Inc. | EIH |
| Feb 1, 2005 | K043312 | NOBELRONDO DENTAL CERAMIC - ZIRCONIA Nobel Biocare USA, LLC | EIH |
| Jan 18, 2005 | K043472 | MEDIN TECH ZIRCONIA-CP10, SS1000 Medin Tech, CA | EIH |
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