K211812 is an FDA 510(k) clearance for the BLUEDIAMOND IMPLANT, Abutment Screw. This device is classified as a Implant, Endosseous, Root-form (Class II - Special Controls, product code DZE).
Submitted by Megagen Implant Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on January 6, 2023, 574 days after receiving the submission on June 11, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640.
| 510(k) Number | K211812 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 11, 2021 |
| Decision Date | January 06, 2023 |
| Days to Decision | 574 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZE — Implant, Endosseous, Root-form |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |