K052462 is an FDA 510(k) clearance for the G-COAT. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on October 20, 2005, 42 days after receiving the submission on September 8, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K052462 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 08, 2005 |
| Decision Date | October 20, 2005 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBD — Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |