K082434 is an FDA 510(k) clearance for the GDLS-200. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on November 14, 2008, 81 days after receiving the submission on August 25, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K082434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 2008 |
| Decision Date | November 14, 2008 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |