K220329 is an FDA 510(k) clearance for the G-CAM. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).
Submitted by Graphenano Dental S.L. (Yecla, ES). The FDA issued a Cleared decision on August 16, 2022, 193 days after receiving the submission on February 4, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.
| 510(k) Number | K220329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2022 |
| Decision Date | August 16, 2022 |
| Days to Decision | 193 days |
| Submission Type | Abbreviated |
| 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 |