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 |
|---|---|---|---|
| Jan 12, 2005 | K043468 | WILLI GELLER CREATION II PORCELAIN Jensen Int'L, Inc. | EIH |
| Jan 11, 2005 | K043462 | CZR PRESS LF Noritake Co., Inc. | EIH |
| Jan 11, 2005 | K043201 | WILLI GELLER CREATION ZI PORCELAIN Jensen Industries, Inc. | EIH |
| Dec 22, 2004 | K043247 | DUCERA ALLCERAM Dentsply Intl. | EIH |
| Dec 20, 2004 | K043221 | WILLI GELLER CREATION CP PORCELAIN Jensen Industries, Inc. | EIH |
| Dec 17, 2004 | K042638 | RADIANCE PORCELAIN Aurident, Inc. | EIH |
| Dec 3, 2004 | K042548 | CERASYS - ZR Cerasys, Inc. | EIH |
| Jul 30, 2004 | K041707 | CERCON CERAM EXPRESS CERAMIC SYSTEM Dentsply Intl. | EIH |
| Jul 23, 2004 | K041312 | NOBELRONDO DENTAL CERAMIC-ALUMINA Nobel Biocare Uas, Inc. | EIH |
| Jul 9, 2004 | K041645 | DDS-ZR Charles Scharf | EIH |
| Jun 16, 2004 | K041335 | PTM SYSTEM Dentsply International | EIH |
| May 20, 2004 | K040859 | HERACERAM PRESS Heraeus Kulzer, Inc. | EIH |
| Apr 22, 2004 | K040567 | GC INITIAL MC, AL AND LF GC America, Inc. | EIH |
| Mar 30, 2004 | K040635 | CARRARA INTERACTION CERAMIC SYSTEM Dentsply Intl. | EIH |
| Mar 18, 2004 | K040421 | DUCERAGOLD PORCELAINS Dentsply Intl. | EIH |
| Mar 18, 2004 | K040420 | DUCERAM PLUS CERAMIC SYSTEM Dentsply Intl. | EIH |
| Feb 5, 2004 | K032416 | VINTAGE PRESS, VINTAGE LF, VINTAGE LF STAIN Shofu Dental Corp. | EIH |
| Jan 23, 2004 | K033667 | CARRARA PRESS SYSTEM Dentsply Intl. | EIH |
| Jan 22, 2004 | K024252 | MATCH MASTER LOW FUSION PORCELAIN Davis Schottlander & Davis, Ltd. | EIH |
| Dec 22, 2003 | K031968 | CERABIEN ZR Noritake Co., Inc. | EIH |
| Dec 2, 2003 | K033553 | PFZ PORCELAIN SYSTEM Dentsply Intl. | EIH |
| Oct 28, 2003 | K033221 | KAVO EVEREST ZH-BLANK Kavo America Corporation | EIH |
| Oct 24, 2003 | K033049 | CZR PRESS Noritake Co., Inc. | EIH |
| Sep 16, 2003 | K032165 | VINTAGE AL Shofu Dental Corp. | EIH |
| Aug 25, 2003 | K024250 | MATCH PRESS PRESSABLE CERAMIC Davis Schottlander & Davis, Ltd. | EIH |
| Jul 24, 2003 | K032081 | KAVO EVEREST ZS-BLANK MODELS, 42, 20, AND 60 Kavo America | EIH |
| Jun 17, 2003 | K031326 | IMAGINE REFLEX Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| May 2, 2003 | K030607 | KAVO EVEREST G-BLANK, KAVO EVEREST G-CERAM, COATING CERAMIC LF-3-PFM, GLAZE AND COLORINGS/STAINING/SHADES Kavo America | EIH |
| Mar 27, 2003 | K030859 | NOVA CERAMIC SPRAY GLAZE AND TRU-PAQUE, OPAQUE PORCELAIN Enamelite, LLC | EIH |
| Dec 2, 2002 | K023327 | CYNOVAD ZIRKON Cynovad, CA | EIH |
| Oct 9, 2002 | K022996 | VITA IN-CERAM YZ CUBES FOR CEREC Vident | EIH |
| Sep 6, 2002 | K022796 | CERCON CERAM S PORCELAIN Dentsply Intl. | EIH |
| Sep 6, 2002 | K022408 | CEREC VITABLOCKS MK2 B.B.'S Prophy Shop, DE | EIH |
| May 22, 2002 | K020774 | IMAGINE H.E. PRESS DESIGN-CERAMIC Wieland Dental + Technik GmbH & Co. KG, DE | EIH |
| Mar 27, 2002 | K020269 | PROCERA ALLCERAM BRIDGE MATERIAL Procera Sandvik AB, SE | EIH |
| Oct 25, 2001 | K013230 | CERCON BASE Degussa - Ney Dental, Inc. | EIH |
| Sep 4, 2001 | K011674 | DC - CRISTAL Austenal, Inc. | EIH |
| Aug 27, 2001 | K012174 | ERIS LAYERING MATERIALS Ivoclar North America, Inc. | EIH |
| Aug 23, 2001 | K012231 | AVANTE MICRO CRYSTAL SYSTEM Jeneric/Pentron, Inc. | EIH |
| Aug 20, 2001 | K011333 | CERCON CERAM Degussa - Ney Dental, Inc. | EIH |
| Aug 16, 2001 | K012156 | IMAGINE H.E. Wieland Edelmetalle GmbH & Co., DE | EIH |
| Jun 29, 2001 | K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM Espe Dental AG, DE | EIH |
| Jun 5, 2001 | K011428 | TRICERAM Dentaurum, Inc. | EIH |
| Jun 5, 2001 | K011425 | CARMEN Dentaurum, Inc. | EIH |
| Apr 17, 2001 | K010630 | Y-TZP POWDER AND PROCERA ALLZIRKON Procera Sandvik, Inc. | EIH |
| Nov 28, 2000 | K003373 | PROCAD ADD-ON Ivoclar North America, Inc. | EIH |
| Nov 16, 2000 | K002993 | HERACERAM J.F. Jelenko & Co., Inc. | EIH |
| Nov 6, 2000 | K002904 | WILLI GELLER CREATION AND LF PORCELAIN Jensen Industries, Inc. | EIH |
| Aug 26, 2000 | K000983 | CERAMIX PORCELAIN SYSTEM C-Mix | EIH |
| Aug 16, 2000 | K002041 | WILLI GELLER CREATION & AV PORCELAIN Jensen Industries, Inc. | EIH |
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