K220366 is an FDA 510(k) clearance for the EmbedMed. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by 3D Lifeprints UK , Ltd. (West Derby, Liverpool, Merseyside, GB). The FDA issued a Cleared decision on September 30, 2022, 234 days after receiving the submission on February 8, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K220366 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2022 |
| Decision Date | September 30, 2022 |
| Days to Decision | 234 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZJ - Driver, Wire, And Bone Drill, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |