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 22, 1992 | K913644 | VITA IN-CERAM Vident | EIH |
| Jun 18, 1992 | K921474 | VITA OMEGA PORCELAIN Vident | EIH |
| Mar 19, 1992 | K915543 | NEW OPAQUE PORCELAIN Dentsply Intl. | EIH |
| Oct 25, 1991 | K913372 | IPS EMPRESS Ivoclar North America, Inc. | EIH |
| Feb 26, 1991 | K905321 | PLATINUM FOIL, VARIOUS SIZES Ivoclar North America, Inc. | EIH |
| Jan 17, 1991 | K905328 | WILL-CERAM BRUSHES, SUPER BRUSH KIT Ivoclar North America, Inc. | EIH |
| Oct 10, 1990 | K901862 | VMK 68 AND VMK 68N DENTAL PORCELAIN KIT Vident | EIH |
| Oct 5, 1990 | K902200 | VITA HI-CERAM Vident | EIH |
| Oct 5, 1990 | K902105 | VITADUR-N DENTAL PORCELAIN KIT Vident | EIH |
| Oct 5, 1990 | K901982 | VITACHROM-L DENTAL PORCELAIN KIT Vident | EIH |
| Aug 3, 1990 | K895731 | DEN-MAT CERINATE PORCELAIN Den-Mat Corp. | EIH |
| Jun 26, 1990 | K901261 | PV-CERAMIC, CERAMINIQUE Ivoclar North America, Inc. | EIH |
| Apr 16, 1990 | K900393 | OPAQUE PORCELAIN Dentsply Intl. | EIH |
| Apr 10, 1990 | K895888 | SILHOUETTE PORCELAIN Leach and Dillon Co., Inc. | EIH |
| Apr 9, 1990 | K900209 | WILLI GELLER CERAMIC CREATION & SURPRISE Creation North America, Inc. | EIH |
| Apr 4, 1990 | K895889 | SHAKE N' SPRAY (W/SILHOUETTE PORCELAIN) Leach and Dillon Co., Inc. | EIH |
| Jan 10, 1989 | K884356 | NORITAKE SUPER PORCELAIN EX-3 Noritake Co., Inc. | EIH |
| Nov 24, 1986 | K864404 | PENTRON HIGH STRENGTH PORCELAIN Pentron Corp. | EIH |
| Mar 6, 1986 | K855037 | TRU-COLOR Veritas Dental Co., Inc. | EIH |
| Feb 21, 1986 | K854763 | CERAPEARL Kyocera International, Inc. | EIH |
| Nov 19, 1985 | K853707 | DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES Dentsply Intl. | EIH |
| Nov 14, 1985 | K853698 | SCOTCHPRIME CERAMIC PRIMER 3M Company | EIH |
| Jul 31, 1985 | K852743 | PORCELAIN VENEER SYSTEM LABORATORY KIT The S. S. White Co. | EIH |
| Apr 8, 1985 | K850821 | CERESTORE DENTIN PORCELAIN Johnson & Johnson Professionals, Inc. | EIH |
| Apr 25, 1984 | K840873 | CRYSTAR PORCELAIN MARGIN POWDER/LIQUID Shofu Dental Corp. | EIH |
| Mar 6, 1984 | K834497 | SHOFU PORCELAIN STAIN Shofu Dental Corp. | EIH |
| Dec 29, 1983 | K833643 | CRYSTAR PORCELAIN Shofu Dental Corp. | EIH |
| Sep 26, 1983 | K832286 | CERESTORE CORE MATERIAL Johnson & Johnson Professionals, Inc. | EIH |
| Jul 28, 1983 | K831483 | SAVE-A-BAKE PORCELAIN POLISH Denpac Corp. | EIH |
| May 9, 1983 | K830955 | DENTAL CERAMIC FOR FABRICATION OF CROWN Dentsply Intl. | EIH |
| Apr 6, 1983 | K830553 | DENTAL PORCELAIN POWDER Dentsply Intl. | EIH |
| Dec 3, 1982 | K823378 | CERA COLOR Cer-Met, Inc. | EIH |
| Dec 3, 1982 | K823377 | CERA 8 Cer-Met, Inc. | EIH |
| Mar 2, 1982 | K820057 | LUXOR PORCELAIN Jeneric Ind. | EIH |
| Apr 21, 1981 | K810822 | DENTAL PORCELAIN POWDER Coors Biomedical Co. | EIH |
| Mar 4, 1981 | K810096 | PORCELAIN POWDER FOR CLINICAL USE Dentsply Intl. | EIH |
| Jan 14, 1981 | K803310 | CERAMCO PORCELAIN Johnson & Johnson Professionals, Inc. | EIH |
| Sep 26, 1980 | K802235 | MICRO-BOND HI-LIFE PROCELAIN & VIVERE Howmedica Corp. | EIH |
| Nov 14, 1977 | K771887 | ACCU-STAIN Williams Gold Refining Co., Inc. | EIH |
| Nov 14, 1977 | K771886 | ACCU-PAQUE Williams Gold Refining Co., Inc. | EIH |
| Jun 3, 1977 | K770932 | GERAMCO LOW TEMP GLAZE Johnson & Johnson Professionals, Inc. | EIH |
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