Data / Medical devices / Germany / Erkodent Erich Kopp GMBH
Erkodent Erich Kopp GMBH: FDA-registered device maker in PFALZGRAFENWEILER Baden-Wurttemberg, Germany, 1 510(k) clearance
Erkodent Erich Kopp GMBH is registered with the FDA (registration 8010662) in PFALZGRAFENWEILER Baden-Wurttemberg, Germany. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8010662
- FEI number
- 5513
- Address
- Siemensstr. 3, PFALZGRAFENWEILER Baden-Wurttemberg, Germany, 72285
- Owner or operator
- Erkodent Erich Kopp GmbH (8010662)
- Roles
- Manufacturer
- First device listed
- May 20, 2004
- Registered through
- 2026
- Brand names listed
- ERKOFLEX AND ERKOPLAST, Erkodur, Erkoflex, Erkolen, Erkolign, Erkoloc-pro, Erkoplast PLA, Playsafe triple
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Positioner, Tooth, Preformed | KMY | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 28, 2020 | K200125 | Thermoforming Sheet Materials | MQC | Substantially Equivalent | Erkodent Erich Kopp GmbH | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Impression, Preformed
- All makers of Mouthguard, Prescription
- All makers of Positioner, Tooth, Preformed
Updated October 28, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.