Company ยท US
Espe GmbH (Us)
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1993. Name variants (Inc, Corp, punctuation) are merged.
59510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 13 |
| EMA | Cement, Dental | 10 |
| KLE | Agent, Tooth Bonding, Resin | 8 |
| ELW | Material, Impression | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 3 |
| EBH | Material, Impression Tray, Resin | 3 |
| EJK | Liner, Cavity, Calcium Hydroxide | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 |
| EID | Syringe, Restorative And Impression Material | 2 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 |
| EBD | Coating, Filling Material, Resin | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 |
| EJH | Alloy, Metal, Base | 1 |
| EJR | Agent, Polishing, Abrasive, Oral Cavity | 1 |
| ELN | Teeth, Preformed Gold Denture | 1 |
| LBH | Varnish, Cavity | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 18, 1993 | K925027 | PHOTAC-FIL APLICAP Espe GmbH (Us), DE | EMA |
| Jan 14, 1992 | K915005 | PHOTAC-BOND APLICAP, MODIFICATION Espe GmbH (Us), DE | EMA |
| Jan 14, 1992 | K913966 | SONO(R) -CEM Espe GmbH (Us), DE | EBF |
| Dec 16, 1991 | K913857 | ROCATEC(R) -PLUS Espe GmbH (Us), DE | EJH |
| Dec 4, 1991 | K913965 | ESPE(R) -SIL Espe GmbH (Us), DE | KLE |
| Mar 29, 1991 | K905604 | VISIO-GEM ART-SYSTEM Espe GmbH (Us) | EBF |
| Nov 19, 1990 | K904096 | PHOTAC-BOND Espe GmbH (Us) | EJK |
| Nov 9, 1990 | K904097 | PHOTAC-BOND APLICAP Espe GmbH (Us) | EJK |
| Nov 1, 1990 | K904289 | PERTAC UNIVERSAL BOND Espe GmbH (Us) | KLE |
| Aug 9, 1990 | K900510 | PERTAC-HYBRID Espe GmbH (Us) | EBF |
| Apr 10, 1990 | K900558 | PERTAC BOND Espe GmbH (Us) | KLE |
| Mar 28, 1990 | K900436 | PROTEMP II Espe GmbH (Us) | EBG |
| Mar 27, 1990 | K897188 | KETAC-CEM MAXICAP Espe GmbH (Us) | EMA |
| Feb 9, 1990 | K896539 | PERMADYNE GARANT LOW VISCOSITY Espe GmbH (Us) | ELW |
| Dec 4, 1989 | K892412 | POLYETHER-RETARDER Espe GmbH (Us) | ELW |
| Oct 27, 1989 | K892839 | PALGARAPID Espe GmbH (Us) | ELW |
| Aug 21, 1989 | K892517 | TULUX-FILTER Espe GmbH (Us) | EBZ |
| May 30, 1989 | K891064 | ESPE CAPMIX Espe GmbH (Us) | EFD |
| May 26, 1989 | K891020 | ESPE TULUX-CEM Espe GmbH (Us) | EBF |
| Jan 19, 1989 | K884752 | KETAC-GLAZE Espe GmbH (Us) | KLE |
| Jan 4, 1989 | K884381 | PALGAFLEX AND PALGAFLEX-QUICK Espe GmbH (Us) | ELW |
| Dec 5, 1988 | K884475 | CHELON-FIL Espe GmbH (Us) | EMA |
| Oct 19, 1988 | K882566 | VISIO-PERL Espe GmbH (Us) | EBF |
| Jul 27, 1988 | K881838 | MODIFIED PERMAGUM ADHESIVE Espe GmbH (Us) | EBH |
| Jul 1, 1988 | K880741 | ESPE VARNISH Espe GmbH (Us) | LBH |
| Apr 12, 1988 | K874788 | KETAC-BOND APLICAP Espe GmbH (Us) | EMA |
| Mar 9, 1988 | K875257 | IMPREGUM F ADHESIVE Espe GmbH (Us) | EBH |
| Mar 9, 1988 | K875228 | PERMADYNE ADHESIVE Espe GmbH (Us) | EBH |
| Mar 9, 1988 | K872984 | KETAC-CONDITIONER Espe GmbH (Us) | EMA |
| Mar 1, 1988 | K875133 | CAVIT-W Espe GmbH (Us) | EBG |
| Feb 26, 1988 | K873882 | ALKALINER Espe GmbH (Us) | EJK |
| Sep 15, 1987 | K873069 | MODIFIED VISIO-SEAL Espe GmbH (Us) | EBC |
| Feb 19, 1987 | K865028 | ESPE CHELON-SILVER Espe GmbH (Us) | EBF |
| Aug 18, 1986 | K862292 | ESPE VISIO-MOLAR Espe GmbH (Us) | EBF |
| Mar 17, 1986 | K853529 | IMPREGUM-F Espe GmbH (Us) | ELW |
| Feb 13, 1986 | K844844 | ESPE NIMETIC-GRIP Espe GmbH (Us) | DYH |
| Aug 19, 1985 | K844845 | ESPE KETAC-BOND Espe GmbH (Us) | EBD |
| Mar 25, 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE Espe GmbH (Us) | EMA |
| Dec 6, 1984 | K843566 | KETAC-SILVER Espe GmbH (Us) | EMA |
| Feb 3, 1984 | K833757 | VISIO-GEM Espe GmbH (Us) | EBF |
| Sep 28, 1982 | K822452 | PROTEMP Espe GmbH (Us) | EBG |
| Sep 14, 1982 | K822453 | VISIO-OPAQUER Espe GmbH (Us) | EBF |
| Sep 8, 1981 | K812169 | VISIO-FIL Espe GmbH (Us) | EBF |
| Oct 22, 1979 | K790823 | VISIO-DISPERS Espe GmbH (Us) | EBF |
| Apr 30, 1979 | K790833 | VISIO-BOND Espe GmbH (Us) | KLE |
| Apr 30, 1979 | K790832 | KETAC APPLIC-CAPSULES Espe GmbH (Us) | EMA |
| Nov 2, 1977 | K771852 | NIMETIC POLISHING PASTE Espe GmbH (Us) | EJR |
| Oct 13, 1977 | K771853 | PERMAGUM ADHESIVE Espe GmbH (Us) | ELW |
| Sep 6, 1977 | K771654 | NIMETICAP Espe GmbH (Us) | EBF |
| Sep 2, 1977 | K771627 | PERMAGUM Espe GmbH (Us) | ELW |
Newest 50 of 59.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||