K201091 is an FDA 510(k) clearance for the V-Print splint. This device is classified as a Mouthguard, Prescription.
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on November 6, 2020, 197 days after receiving the submission on April 23, 2020.
This device falls under the Dental FDA review panel.
| 510(k) Number | K201091 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2020 |
| Decision Date | November 06, 2020 |
| Days to Decision | 197 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | MQC — Mouthguard, Prescription |
| Device Class | — |