Materialise NV - FDA 510(k) Cleared Devices
Recent clearances: CMF Titanium Splints, Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner, Mimics Thoracic Planner
62
Total
62
Cleared
0
Denied
FDA 510(k) Regulatory Record - Materialise NV Dental ✕
6 devices
Cleared
Oct 09, 2026
CMF Titanium Splints
Dental
204d
Cleared
Feb 21, 2025
Materialise Personalized Guides and Models for Craniomaxillofacial Surgery
Dental
88d
Cleared
May 31, 2024
Mimics Enlight CMF
Dental
564d
Cleared
Jul 10, 2018
TruMatch CMF Titanium 3D Printed Implant
Dental
285d
Cleared
Aug 08, 2017
TruMatch CMF Titanium 3D Printed Implant System
Dental
190d
Cleared
Mar 18, 2011
SURGICASE CMF, SURGICASE CONNECT, SURGICASE GUIDE
Dental
144d