K043168 is an FDA 510(k) clearance for the BISCOVER LV. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on February 1, 2005, 77 days after receiving the submission on November 16, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K043168 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 16, 2004 |
| Decision Date | February 01, 2005 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBD — Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |