Not currently registered with FDA under this name
3M Espe AG
Bavaria D-82228 Seefeld, Germany. Named as applicant on 6 dental 510(k) clearances between 2011 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 62011–2014
- Markets registered in
- 540 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name 3M Espe 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 | 3M Espe AG | 6 clearances | 2011–2014 | Below |
| Taiwan | TFDA | Manufacturer | 3M ESPE AG.3M ESPE AG | 11 | 2004–2009 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | 3M ESPE AG3M ESPE / AG | 10 | 2009–2012 | Pure Global AI |
| South Korea | MFDS | Manufacturer | 3M ESPE AG3M ESPE AG. | 10 | 2001–2009 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | 3M ESPE AG | 9 | — | 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 3M Espe AG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 5 Jun 2014 | K140602 | FLASH PENTA MB QUICK, FLASH MB QUICK | ELW Impression Material |
| 6 Mar 2014 | K133400 | FLASH BITE | ELW Impression Material |
| 13 Jan 2012 | K120011 | HEISENBERG EFFECT SHADES | EIH Porcelain Powder |
| 3 Jun 2011 | K110508 | SUGLUE-10 | EMA Dental Cement |
| 19 May 2011 | K110302 | ADHESIVE EXL-759 | KLE Resin Tooth Bonding Agent |
| 13 May 2011 | K111257 | HEISENBERG DYEING LIQUIDS | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: Solventum US LLC (4).
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.