K203596 is an FDA 510(k) clearance for the Panthera Occlusal Appliance. This device is classified as a Mouthguard, Prescription.
Submitted by Panthera Dental, Inc. (Quebec, CA). The FDA issued a Cleared decision on April 20, 2021, 132 days after receiving the submission on December 9, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K203596 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2020 |
| Decision Date | April 20, 2021 |
| Days to Decision | 132 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |