K082449 is an FDA 510(k) clearance for the BISCEM TRANSLUCENT, MODEL D-45011. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).
Submitted by Bisco, Inc. (Schaumburg, US). The FDA issued a Cleared decision on September 25, 2008, 31 days after receiving the submission on August 25, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.
| 510(k) Number | K082449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2008 |
| Decision Date | September 25, 2008 |
| Days to Decision | 31 days |
| Submission Type | Special |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EMA — Cement, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3275 |