K151541 is an FDA 510(k) clearance for the G-Fix. 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 October 9, 2015, 123 days after receiving the submission on June 8, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K151541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 08, 2015 |
| Decision Date | October 09, 2015 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBF — Material, Tooth Shade, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3690 |