K053391 is an FDA 510(k) clearance for the X-TRA FIL. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on February 15, 2006, 72 days after receiving the submission on December 5, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K053391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2005 |
| Decision Date | February 15, 2006 |
| Days to Decision | 72 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 |