CMF Titanium Splints— 510(k) K260913
Substantially EquivalentMaterialise NV
FDA 510(k) clearance K260913 for CMF Titanium Splints, Substantially Equivalent on 2026-10-09. Applicant: Materialise NV. Device class: 2.
Summary
CMF Titanium Splints from Materialise are filed under DZJ, the dental product code for manual wire drivers and bone drills. That's an unexpected code for a product named as splints, and the record doesn't explain the fit.
Class II, 21 CFR 872.4120. The Dental panel reviewed it as a Traditional 510(k).
Materialise filed from Leuven, Belgium. Review took 204 days (March 19 to October 9, 2026).
Clearance details
- Applicant
- Materialise NV
- Product code
- Product 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
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Data sourced from openFDA. This site is unofficial and independent of the FDA.