K222604 is an FDA 510(k) clearance for the dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S. This device is classified as a Mouthguard, Prescription.
Submitted by Dentona AG (Dortmund, DE). The FDA issued a Cleared decision on April 21, 2023, 235 days after receiving the submission on August 29, 2022.
This device falls under the Dental FDA review panel.
| 510(k) Number | K222604 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2022 |
| Decision Date | April 21, 2023 |
| Days to Decision | 235 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |