Not currently registered with FDA under this name
Espe GmbH & Co. Kg.
Seefeld, Germany. Named as applicant on 17 dental 510(k) clearances between 1995 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 171995–1998
- Markets registered in
- 21 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Espe GmbH & Co. Kg. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Espe GmbH & Co. Kg. | 17 clearances | 1995–1998 | Below |
| South Korea | MFDS | Manufacturer | Espe GMBH & CO,KG | 1 | 1998–1998 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Espe GmbH & Co. Kg. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Jan 1998 | K974231 | POSITION PENTA, POSITION PENTA QUICK | ELW Impression Material |
| 22 Dec 1997 | K973513 | SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER | EBF Resin Tooth Shade Material |
| 17 Nov 1997 | K973262 | KETAC-FIL APLICAP PLUS | EMA Dental Cement |
| 2 Oct 1997 | K972892 | CAVIT-LC | EBF Resin Tooth Shade Material |
| 27 Nov 1996 | K963735 | COJET SYSTEM | EBF Resin Tooth Shade Material |
| 15 Nov 1996 | K963737 | HYCEM APLICAP | EMA Dental Cement |
| 12 Sep 1996 | K962428 | EBS (ESPE BONDING SYSTEM) | KLE Resin Tooth Bonding Agent |
| 11 Sep 1996 | K962442 | HYTAC APLITIP/HYTAC OSB | EBF Resin Tooth Shade Material |
| 11 Sep 1996 | K962440 | PERTAC II/PERTAC II APLITIP | EBF Resin Tooth Shade Material |
| 16 May 1996 | K960954 | KETAC-MOLAR APLICAP | EMA Dental Cement |
| 15 Mar 1996 | K960547 | DIMENSION PENTA/DIMENSION GARANT L/POLYVINYL SILOXANE ADHESIVE | ELW Impression Material |
| 1 Dec 1995 | K954192 | IMPREGUM PENTA | ELW Impression Material |
| 21 Nov 1995 | K954180 | MICROGLISS | ELW Impression Material |
| 18 Aug 1995 | K953374 | PERMADYNE GARANT 2:1 | ELW Impression Material |
| 18 Aug 1995 | K952693 | RAMITEC PENTA | ELW Impression Material |
| 19 Jul 1995 | K953027 | PERMADYNE PENTA (HIGH & LOW VISCOSITY) | ELW Impression Material |
| 2 Feb 1995 | K950203 | PROTEMP(R) GARANT | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (7).
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.