K220648 is an FDA 510(k) clearance for the OMF ASP System. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by Vha Dean (Washington, US). The FDA issued a Cleared decision on August 11, 2022, 157 days after receiving the submission on March 7, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K220648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 07, 2022 |
| Decision Date | August 11, 2022 |
| Days to Decision | 157 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 |