K231591 is an FDA 510(k) clearance for the V-Print c&b temp. This device is classified as a Crown And Bridge, Long-term Temporary, Resin (Class II - Special Controls, product code POW).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 31, 2023, 60 days after receiving the submission on June 1, 2023.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770. For The Fabrication Of Long-term Temporary Crowns And Bridges.
| 510(k) Number | K231591 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2023 |
| Decision Date | July 31, 2023 |
| Days to Decision | 60 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | POW — Crown And Bridge, Long-term Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |
| Definition | For The Fabrication Of Long-term Temporary Crowns And Bridges |