K210940 is an FDA 510(k) clearance for the LuxaPrint Ortho Plus. This device is classified as a Mouthguard, Prescription.
Submitted by Dmg Digital Enterprises SE (Hamburg, DE). The FDA issued a Cleared decision on September 3, 2021, 158 days after receiving the submission on March 29, 2021.
This device falls under the Dental FDA review panel.
| 510(k) Number | K210940 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2021 |
| Decision Date | September 03, 2021 |
| Days to Decision | 158 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MQC - Mouthguard, Prescription |
| Device Class | - |