Manufacturer registered with FDA
Erkodent Erich Kopp GmbH
Pfalzgrafenweiler, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 8
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1048 registrations outside the US
- Establishments
- 1Germany
Registered in 10 markets
Where regulators' registries name Erkodent Erich Kopp GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Erkodent Erich Kopp GmbH | 2 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Erkodent Erich Kopp GmbH | 11 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Erkodent Erich Kopp GmbH | 9 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ERKODENT ERICH KOPP GMBH | 6 | 2007–2019 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Erkodent Erich Kopp GmbH | 6 | 2021–2021 | Pure Global AI |
| Australia | TGA | Manufacturer | Erkodent Erich Kopp GmbH | 4 | 2023–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Erkodent Erich Kopp GmbHERKODENT Erich Kopp GmbH | 4 | 2001–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ERKODENT ERICH KOPP GMBH | 4 | 2011–2025 | Pure Global AI |
| China | NMPA | Registration holder | 德国爱科特公司ERKODENT Erich Kopp GmbH | 2 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Erkodent Erich Kopp GmbH | 2 | — | 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
Devices listed with FDA
What Erkodent Erich Kopp GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | ERKOFLEX AND ERKOPLAST | 2004 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | ErkodurErkoflexErkolenErkolignErkoloc-proErkoplast PLAPlaysafe triple | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ERKODENT ERICH KOPP GMBHFDA reg. 8010662 | PFALZGRAFENWEILER Baden-Wurttemberg, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010662). 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.