Clearance Summary
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery received FDA 510(k) clearance under submission number K243637, sponsored by Materialise NV. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2025-02-21.
- Submission: K243637
- Applicant / Sponsor: Materialise NV
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.4120
- Decision date: 2025-02-21
Classification & Regulation
This clearance is catalogued under FDA product code DZJ and 21 CFR 872.4120, within the Dental review panel as a Class II device.