Not currently registered with FDA under this name
Espe GmbH (Us)
West Germany, Germany. Named as applicant on 59 dental 510(k) clearances between 1977 and 1993. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 591977–1993
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1976–2026
510(k) clearances
Clearances on which FDA names Espe GmbH (Us) as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Jun 1993 | K925027 | PHOTAC-FIL APLICAP | EMA Dental Cement |
| 14 Jan 1992 | K915005 | PHOTAC-BOND APLICAP, MODIFICATION | EMA Dental Cement |
| 14 Jan 1992 | K913966 | SONO(R) -CEM | EBF Resin Tooth Shade Material |
| 16 Dec 1991 | K913857 | ROCATEC(R) -PLUS | EJH Base Metal Alloy |
| 4 Dec 1991 | K913965 | ESPE(R) -SIL | KLE Resin Tooth Bonding Agent |
| 29 Mar 1991 | K905604 | VISIO-GEM ART-SYSTEM | EBF Resin Tooth Shade Material |
| 19 Nov 1990 | K904096 | PHOTAC-BOND | EJK Calcium Hydroxide Cavity Liner |
| 9 Nov 1990 | K904097 | PHOTAC-BOND APLICAP | EJK Calcium Hydroxide Cavity Liner |
| 1 Nov 1990 | K904289 | PERTAC UNIVERSAL BOND | KLE Resin Tooth Bonding Agent |
| 9 Aug 1990 | K900510 | PERTAC-HYBRID | EBF Resin Tooth Shade Material |
| 10 Apr 1990 | K900558 | PERTAC BOND | KLE Resin Tooth Bonding Agent |
| 28 Mar 1990 | K900436 | PROTEMP II | EBG Resin Temporary Crown and Bridge |
| 27 Mar 1990 | K897188 | KETAC-CEM MAXICAP | EMA Dental Cement |
| 9 Feb 1990 | K896539 | PERMADYNE GARANT LOW VISCOSITY | ELW Impression Material |
| 4 Dec 1989 | K892412 | POLYETHER-RETARDER | ELW Impression Material |
| 27 Oct 1989 | K892839 | PALGARAPID | ELW Impression Material |
| 21 Aug 1989 | K892517 | TULUX-FILTER | EBZ Ultraviolet Activator for Polymerization |
| 30 May 1989 | K891064 | ESPE CAPMIX | EFD Ac-Powered Dental Amalgamator |
| 26 May 1989 | K891020 | ESPE TULUX-CEM | EBF Resin Tooth Shade Material |
| 19 Jan 1989 | K884752 | KETAC-GLAZE | KLE Resin Tooth Bonding Agent |
| 4 Jan 1989 | K884381 | PALGAFLEX AND PALGAFLEX-QUICK | ELW Impression Material |
| 5 Dec 1988 | K884475 | CHELON-FIL | EMA Dental Cement |
| 19 Oct 1988 | K882566 | VISIO-PERL | EBF Resin Tooth Shade Material |
| 27 Jul 1988 | K881838 | MODIFIED PERMAGUM ADHESIVE | EBH Resin Impression Tray Material |
| 1 Jul 1988 | K880741 | ESPE VARNISH | LBH Cavity Varnish |
| 12 Apr 1988 | K874788 | KETAC-BOND APLICAP | EMA Dental Cement |
| 9 Mar 1988 | K875257 | IMPREGUM F ADHESIVE | EBH Resin Impression Tray Material |
| 9 Mar 1988 | K875228 | PERMADYNE ADHESIVE | EBH Resin Impression Tray Material |
| 9 Mar 1988 | K872984 | KETAC-CONDITIONER | EMA Dental Cement |
| 1 Mar 1988 | K875133 | CAVIT-W | EBG Resin Temporary Crown and Bridge |
| 26 Feb 1988 | K873882 | ALKALINER | EJK Calcium Hydroxide Cavity Liner |
| 15 Sep 1987 | K873069 | MODIFIED VISIO-SEAL | EBC Pit and Fissure Sealant and Conditioner |
| 19 Feb 1987 | K865028 | ESPE CHELON-SILVER | EBF Resin Tooth Shade Material |
| 18 Aug 1986 | K862292 | ESPE VISIO-MOLAR | EBF Resin Tooth Shade Material |
| 17 Mar 1986 | K853529 | IMPREGUM-F | ELW Impression Material |
| 13 Feb 1986 | K844844 | ESPE NIMETIC-GRIP | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 19 Aug 1985 | K844845 | ESPE KETAC-BOND | EBD Resin Filling Material Coating |
| 25 Mar 1985 | K844846 | ESPE KETAC-CEM RADIOPAQUE | EMA Dental Cement |
| 6 Dec 1984 | K843566 | KETAC-SILVER | EMA Dental Cement |
| 3 Feb 1984 | K833757 | VISIO-GEM | EBF Resin Tooth Shade Material |
| 28 Sep 1982 | K822452 | PROTEMP | EBG Resin Temporary Crown and Bridge |
| 14 Sep 1982 | K822453 | VISIO-OPAQUER | EBF Resin Tooth Shade Material |
| 8 Sep 1981 | K812169 | VISIO-FIL | EBF Resin Tooth Shade Material |
| 22 Oct 1979 | K790823 | VISIO-DISPERS | EBF Resin Tooth Shade Material |
| 30 Apr 1979 | K790833 | VISIO-BOND | KLE Resin Tooth Bonding Agent |
| 30 Apr 1979 | K790832 | KETAC APPLIC-CAPSULES | EMA Dental Cement |
| 2 Nov 1977 | K771852 | NIMETIC POLISHING PASTE | EJR Oral Cavity Abrasive Polishing Agent |
| 13 Oct 1977 | K771853 | PERMAGUM ADHESIVE | ELW Impression Material |
| 6 Sep 1977 | K771654 | NIMETICAP | EBF Resin Tooth Shade Material |
| 2 Sep 1977 | K771627 | PERMAGUM | ELW Impression Material |
| 3 Aug 1977 | K771328 | UVIOBOND | KLE Resin Tooth Bonding Agent |
| 2 Aug 1977 | K771327 | UVIOFIL | EBC Pit and Fissure Sealant and Conditioner |
| 2 Aug 1977 | K771326 | NIMETIC BONDING MATERIAL | KLE Resin Tooth Bonding Agent |
| 2 Aug 1977 | K771325 | NIMETIC ETCHING GEL | KLE Resin Tooth Bonding Agent |
| 3 Jun 1977 | K770931 | APPLIC SYSTEM APPLIER, ESPE | EID Restorative and Impression Material Syringe |
| 2 Jun 1977 | K770941 | APPLIC SYSTEM ACTIVATOR, ESPE | EID Restorative and Impression Material Syringe |
| 1 Jun 1977 | K770923 | ESPETEMP (TEMP. CEMENT) | EMA Dental Cement |
| 1 Jun 1977 | K770922 | DENTAL RESTORATIVE IN CAPSULES | EBF Resin Tooth Shade Material |
| 1 Jun 1977 | K770872 | IMPRESSION MATERIAL, ALGINATE | ELN Preformed Gold Denture Teeth |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (13).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.