K221022 is an FDA 510(k) clearance for the NextDent Ortho Flex. This device is classified as a Mouthguard, Prescription.
Submitted by Vertex-Dental B.V. (Soesterberg, NL). The FDA issued a Cleared decision on October 21, 2022, 198 days after receiving the submission on April 6, 2022.
This device falls under the Dental FDA review panel.
| 510(k) Number | K221022 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 2022 |
| Decision Date | October 21, 2022 |
| Days to Decision | 198 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |