K243637 is an FDA 510(k) clearance for the Materialise Personalized Guides and Models for Craniomaxillofacial Surgery. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by Materialise NV (Leuven, BE). The FDA issued a Cleared decision on February 21, 2025, 88 days after receiving the submission on November 25, 2024.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K243637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2024 |
| Decision Date | February 21, 2025 |
| Days to Decision | 88 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 |