Material, Impression Tray, Resin
Regulation 872.3670
0510(k)s in 12 months (30 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in EBH
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 5 | 0 |
| Espe GmbH (Us) | 3 | 0 |
| Dentron, Inc. | 2 | 0 |
| Heraeus Kulzer, Inc. | 2 | 0 |
| Kulzer, Inc. | 2 | 0 |
| 3M Company | 1 | 0 |
| Advantage Dental Products, Inc. | 1 | 0 |
| Bio-Systems Research | 1 | 0 |
| Chayet and Sonnenrich, P.C. | 1 | 0 |
| Cutter Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 26, 1994 | K933745 | PERMAGEN UNIVERSAL BONDING RESIN Bio-Systems Research | EBH |
| Jun 18, 1993 | K930487 | PALATRAY LC MINT Heraeus Kulzer, Inc. | EBH |
| Nov 17, 1992 | K923979 | LC TRAY MATERIAL Dentsply Intl. | EBH |
| Sep 29, 1992 | K923549 | PALADISC LC Heraeus Kulzer, Inc. | EBH |
| Aug 21, 1991 | K912820 | POLYESTER RESIN HAND MOLDED TRAY E&D Dental Products, Inc. | EBH |
| Jun 6, 1991 | K905058 | PALAVIT L Kulzer, Inc. | EBH |
| Jul 26, 1990 | K902350 | PALATRAY LC RESIN IMPRESSION TRAY MATERIAL Kulzer, Inc. | EBH |
| Jun 29, 1990 | K901782 | CONVERTRAY CUSTOM IMPRESSION TRAY MATERIAL SYSTEM Productivity Training Corp. | EBH |
| Apr 25, 1989 | K890712 | ADVANTAGE DENTAL CUST DENT IMPRESS/BASEPLATE TRAYS Advantage Dental Products, Inc. | EBH |
| Jul 27, 1988 | K881838 | MODIFIED PERMAGUM ADHESIVE Espe GmbH (Us) | EBH |
| Mar 9, 1988 | K875257 | IMPREGUM F ADHESIVE Espe GmbH (Us) | EBH |
| Mar 9, 1988 | K875228 | PERMADYNE ADHESIVE Espe GmbH (Us) | EBH |
| Mar 7, 1988 | K873739 | ACRYLIC IMPRESSION TRAY MATERIALS E&D Dental Manufacturing Co. | EBH |
| Jun 22, 1987 | K872210 | IMPRESSION TRAY Dentsply Intl. | EBH |
| Nov 3, 1986 | K863421 | SR-IVOLEN TRAY MATERIAL Ivoclar USA, Inc. | EBH |
| Nov 7, 1985 | K854042 | RESIN TRAY IMPRESSION MATERIAL Dentsply Intl. | EBH |
| Sep 6, 1985 | K853093 | PSP TEMP - TRAY Psp Dental Co., Ltd., GB | EBH |
| Jul 2, 1985 | K852182 | EASY TRAY & EASY BASE CUSTOM IMPRESSION TRAY MATER The S. S. White Co. | EBH |
| Feb 8, 1985 | K844471 | VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE Dentsply Intl. | EBH |
| Jan 23, 1985 | K850014 | HIT KIT (HYDRODYNAMIC IMPRESSION TECHNIQUE Medi-Dent American, Inc. | EBH |
| Jul 26, 1983 | K831293 | SOLARCRYL CUSTOM TRAY MATERIAL Solar Dental Co., Inc. | EBH |
| Jun 10, 1982 | K820998 | DENTRON-DIRECT-TRAY Dentron, Inc. | EBH |
| Jun 10, 1982 | K820997 | DENTRON-EXACT - TRAY Dentron, Inc. | EBH |
| Feb 24, 1982 | K813550 | HYBRID DENTAL PRODUCT Dentsply Intl. | EBH |
| Apr 14, 1981 | K810686 | SR-IVOLEN J. Aderer, Inc. | EBH |
| Nov 12, 1980 | K802751 | P-10 POSTERIOR FILLING MATERIAL 3M Company | EBH |
| Aug 7, 1980 | K801780 | OXY CUSTOM TRAY RESIN Oxy Dental Products, Inc. | EBH |
| Jun 15, 1979 | K790897 | QUAD IV CUSTOM IMPRESSION TRAY Sted, Inc. | EBH |
| Feb 26, 1979 | K782153 | IMPRESSION TRAY, MDDS CUSTOM Chayet and Sonnenrich, P.C. | EBH |
| Oct 15, 1976 | K760754 | CUTTER TRAY-ACRYLIC FOR IMP TRAYS Cutter Laboratories, Inc. | EBH |
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