K053392 is an FDA 510(k) clearance for the FUTURABOND NR SINGLE DOSE. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on December 15, 2005, 10 days after receiving the submission on December 5, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.
| 510(k) Number | K053392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 2005 |
| Decision Date | December 15, 2005 |
| Days to Decision | 10 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | KLE — Agent, Tooth Bonding, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3200 |