Materialise Personalized Guides and Models for Craniomaxillofacial Surgery— 510(k) K243637
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K243637 for Materialise Personalized Guides and Models for Craniomaxillofacial Surgery, Substantially Equivalent on 2025-02-21. Applicant: Materialise NV. Device class: 2.
Clearance details
- Applicant
- Materialise NV
- Product code
- Code DZJ
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Leuven, BE
Recent devices under product code DZJ
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- K251554 — Materialise TKA Guide System
Data sourced from openFDA. This site is unofficial and independent of the FDA.