K130485 is an FDA 510(k) clearance for the CONTROL SEAL. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II - Special Controls, product code EBC).
Submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on February 11, 2014, 351 days after receiving the submission on February 25, 2013.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K130485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2013 |
| Decision Date | February 11, 2014 |
| Days to Decision | 351 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBC — Sealant, Pit And Fissure, And Conditioner |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3765 |