K200125 is an FDA 510(k) clearance for the Thermoforming Sheet Materials. This device is classified as a Mouthguard, Prescription.
Submitted by Erkodent Erich Kopp GmbH (Pfalzgrafenweiler, DE). The FDA issued a Cleared decision on October 28, 2020, 281 days after receiving the submission on January 21, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K200125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2020 |
| Decision Date | October 28, 2020 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |