K241311 is an FDA 510(k) clearance for the Thermoforming Sheet Materials (Track A). This device is classified as a Mouthguard, Prescription.
Submitted by Bernhard F?rster GmbH (Pforzheim, DE). The FDA issued a Cleared decision on August 2, 2024, 85 days after receiving the submission on May 9, 2024.
This device falls under the Dental FDA review panel.
| 510(k) Number | K241311 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 09, 2024 |
| Decision Date | August 02, 2024 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |