K062344 is an FDA 510(k) clearance for the GRANDIO 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 October 2, 2006, 52 days after receiving the submission on August 11, 2006.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.
| 510(k) Number | K062344 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2006 |
| Decision Date | October 02, 2006 |
| Days to Decision | 52 days |
| Submission Type | Abbreviated |
| 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 |