510(k) clearance
CMF Titanium Splints
- 510(k) number
- K260913
- Applicant
- Materialise NV
- Decision date
- Oct 9, 2026
- Date received
- Mar 19, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- DZJ
- Device type
- Driver, Wire, And Bone Drill, Manual
- Device class
- Class II
- Regulation
- 21 CFR 872.4120
- Advisory committee
- Dental
- Statement or summary
- Summary
- Third party
- N
- Location
- Leuven, BE