Not currently registered with FDA under this name
Espe Dental AG
Bavaria D-82228 Seefeld, Germany. Named as applicant on 29 dental 510(k) clearances between 1998 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 291998–2001
- Markets registered in
- 231 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Espe Dental AG 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 Dental AG | 29 clearances | 1998–2001 | Below |
| South Korea | MFDS | Manufacturer | ESPE DENTAL AGESPE Dental AG · Espe Dental AG · +2 | 31 | 1998–2000 | 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 Dental AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 29 Jun 2001 | K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | EIH Porcelain Powder |
| 16 May 2001 | K011154 | ELIPAR FREELIGHT | EBZ Ultraviolet Activator for Polymerization |
| 26 Sep 2000 | K002793 | KETAC CEM U | EMA Dental Cement |
| 10 Aug 2000 | K002364 | PROTEMP H | EBG Resin Temporary Crown and Bridge |
| 7 Jul 2000 | K001494 | MODIFICATION TO PROMPT L-POP | KLE Resin Tooth Bonding Agent |
| 5 Apr 2000 | K000595 | DIMENSION PENTA L | ELW Impression Material |
| 30 Mar 2000 | K000591 | DIMENSION PENTA H, DIMENSION PENTA H QUICK | ELW Impression Material |
| 30 Mar 2000 | K000588 | DIMENSION GARANT L, DIMENSION GARANT L QUICK | ELW Impression Material |
| 28 Jan 2000 | K994193 | IMPREGUM PENTA DUOSOFT | ELW Impression Material |
| 28 Jan 2000 | K994192 | IMPREGUM PENTA M MONOSOFT | ELW Impression Material |
| 27 Jan 2000 | K994190 | IMPREGUM GARANT L DUOSOFT | ELW Impression Material |
| 3 Jan 2000 | K994251 | KETAC-MOLAR QUICK | EBF Resin Tooth Shade Material |
| 6 Dec 1999 | K993566 | PROMPTFLOW | EBF Resin Tooth Shade Material |
| 24 Nov 1999 | K992909 | HYTAC | EBF Resin Tooth Shade Material |
| 7 Oct 1999 | K992966 | REFERENCE | EBF Resin Tooth Shade Material |
| 22 Sep 1999 | K992645 | SINFONY | EBF Resin Tooth Shade Material |
| 8 Sep 1999 | K992897 | IMPREGUM PENTA | ELW Impression Material |
| 8 Sep 1999 | K992895 | IMPREGUM F | ELW Impression Material |
| 16 Aug 1999 | K992048 | MODIFICATION OF PROMPT L-POP | KLE Resin Tooth Bonding Agent |
| 26 Jul 1999 | K991913 | PENTAMIX 2 | EFD Ac-Powered Dental Amalgamator |
| 18 Jun 1999 | K991008 | DIMENSION BITE | ELW Impression Material |
| 25 May 1999 | K990763 | VITRON M | EBI Rebasing Repairing Relining Denture Resin |
| 20 May 1999 | K991221 | VESTOGUM | ELW Impression Material |
| 20 May 1999 | K991220 | VITRON H | EBI Rebasing Repairing Relining Denture Resin |
| 23 Apr 1999 | K990982 | CAVIT LC | EBF Resin Tooth Shade Material |
| 25 Feb 1999 | K984247 | ELIPAR TRILIGHT | EBZ Ultraviolet Activator for Polymerization |
| 8 Jan 1999 | K984248 | PROCEM | EMA Dental Cement |
| 8 Jan 1999 | K984246 | PROMPT L-POP | KLE Resin Tooth Bonding Agent |
| 16 Dec 1998 | K983414 | EVERBOND | KLE Resin Tooth Bonding Agent |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (15), Jensen Industries, Inc. (1), Five Star Orthodontic Laboratory & Supply, Inc. (1).
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.