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 |
|---|---|---|---|
| Aug 10, 2000 | K001815 | DC ZIRKON Austenal, Inc. | EIH |
| Jul 5, 2000 | K001418 | ALUMINUM OXIDE POWDER, SUMICORUNDUM AAO4S Procera Sandvik, Inc. | EIH |
| May 25, 2000 | K000680 | VISION ESTHETIC PORCELAIN SYSTEM Midatlantic Division of Dentrex, Inc. | EIH |
| May 17, 2000 | K000597 | VITA RESPONSE Vident | EIH |
| Feb 10, 2000 | K994435 | OPC 3G ALL-CERAMIC SYSTEM, CORE AND OVERLAY PORCELAINS Jeneric/Pentron, Inc. | EIH |
| Jan 11, 2000 | K992489 | 3M TR SYSTEM 3M Company | EIH |
| Jan 10, 2000 | K993897 | CERGOGOLD Degussa - Ney Dental, Inc. | EIH |
| Nov 29, 1999 | K993249 | OPC LOW WEAR OPAQUE PORCELAIN Jeneric/Pentron, Inc. | EIH |
| Sep 29, 1999 | K984201 | DENZIR Dentronic AB, SE | EIH |
| Sep 22, 1999 | K992161 | CERANA Nordiska Dental AB | EIH |
| Sep 3, 1999 | K992023 | GRAND CERAM Noritake Co., Inc. | EIH |
| Aug 27, 1999 | K992024 | SUPER PORCELAIN TI-22 Noritake Co., Inc. | EIH |
| Jul 21, 1999 | K991844 | PRO-GLASS Cad Cam Ventures | EIH |
| Apr 6, 1999 | K990817 | IPS D.SIGN PORCELAIN Ivoclar North America, Inc. | EIH |
| Apr 2, 1999 | K990790 | VISION PORCELAIN Servo Dental USA, Inc. | EIH |
| Mar 19, 1999 | K990629 | SYMBIOCERAM Ney Dental, Inc. | EIH |
| Mar 15, 1999 | K984427 | EXCELSIOR PORCELAIN SYSTEM Ney Dental, Inc. | EIH |
| Dec 22, 1998 | K983470 | SUPER PORCELAIN STAIN- PURE WHITE Noritake Co., Inc. | EIH |
| Nov 18, 1998 | K983453 | PROCERA ALLCERAM FUSING MATERIAL Nobel Biocare Uas, Inc. | EIH |
| Nov 3, 1998 | K983247 | SUPER PORCELAIN ADDMATE Noritake Co., Inc. | EIH |
| Oct 30, 1998 | K982766 | PASTE OPAQUE EX-3 Noritake Co., Inc. | EIH |
| Oct 22, 1998 | K981490 | WILLI GELLER CREATION PORCELAIN Jensen Industries, Inc. | EIH |
| Sep 8, 1998 | K982616 | IPS EMPRESS 2 Ivoclar North America, Inc. | EIH |
| Aug 18, 1998 | K982377 | OPC LOWWEAR PORCELAIN Jeneric/Pentron, Inc. | EIH |
| Aug 4, 1998 | K982129 | ANTAGON PORCELAIN European Dental Imports, Inc. | EIH |
| Aug 2, 1998 | K982664 | VITA TITANIUM PORCELAIN Vident | EIH |
| Jul 10, 1998 | K981524 | PRILANE Gresco Products, Inc. | EIH |
| May 15, 1998 | K981000 | CARRARA PORCELAIN AND CARRARA VINCENT PORCELAIN European Dental Imports, Inc. | EIH |
| May 11, 1998 | K980986 | PROCAD Ivoclar USA, Inc. | EIH |
| Oct 30, 1997 | K972648 | SONICSYS INLAY Ivoclar North America, Inc. | EIH |
| Oct 16, 1997 | K973247 | VINTAGE HALO Shofu Dental Corp. | EIH |
| Sep 17, 1997 | K972827 | IPS EMPRESS COSMO INGOT Ivoclar North America, Inc. | EIH |
| Sep 11, 1997 | K971869 | FINESSE ALL-CERAMIC SYSTEM Dentsply Intl. | EIH |
| Apr 16, 1997 | K970941 | SLIPPERY GLASS Jeneric/Pentron, Inc. | EIH |
| May 28, 1996 | K961291 | FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS Dentsply Intl. | EIH |
| Dec 11, 1995 | K955070 | OPTIBOND; OPTIAID, OPTIREP, OPTISHINE, OPTICHROMA, OPTIFARB & OPTIWAK Optimal Dental (Usa) | EIH |
| Nov 2, 1995 | K954761 | FINESSE LOW-FUSING PORCELAIN SYSTEM Dentsply Intl. | EIH |
| May 10, 1995 | K951582 | ULTRADENT PORCELAIN ETCH Ultradent Products, Inc. | EIH |
| May 2, 1995 | K951183 | IN-CERAM SPINELL Vident | EIH |
| Dec 2, 1994 | K944702 | PROCERA ALL-CERAMIC PORCELAIN Nobelpharma USA, Inc. | EIH |
| Aug 29, 1994 | K943582 | SOFTWEAR PORCELAIN SYSTEM Dentsply Intl. | EIH |
| Mar 18, 1994 | K934195 | VITA CELAY BLANKS AND VITA CELAY OPTIMIZER Vident | EIH |
| Mar 1, 1994 | K940252 | FINESSE PORCELAIN SYSTEM Dentsply Intl. | EIH |
| Jul 8, 1993 | K932039 | G-CERA ORBIT COLOUR COMMUNICATION SET GC America, Inc. | EIH |
| Apr 8, 1993 | K915653 | KERAMAIL Wilde-USA, Inc. | EIH |
| Mar 31, 1993 | K926238 | BISCO PORCELAIN ETCHING GEL Bisco, Inc. | EIH |
| Mar 16, 1993 | K923717 | JELENKO PORCELAIN SYSTEM PVS PROCELAIN J.F. Jelenko & Co., Inc. | EIH |
| Jul 2, 1992 | K921623 | VITADUR ALPHA PORCELAIN Vident | EIH |
| Jul 2, 1992 | K921619 | DENTAL PORCELAIN Dentsply Intl. | EIH |
| Jun 22, 1992 | K921479 | DUCERATIN/DUCERAM LFC DENTAL PORCELAIN Degussa AG | EIH |
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