K152373 is an FDA 510(k) clearance for the VITA VM LC Flow. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Vita Zahnfabrik H.Rauter GmbH & Co. (Bad Sackingen, DE). The FDA issued a Cleared decision on December 30, 2015, 131 days after receiving the submission on August 21, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K152373 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2015 |
| Decision Date | December 30, 2015 |
| Days to Decision | 131 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF - Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |