MEDIUMRegulatoryTier 1
FDA 510(k) K260913: CMF Titanium Splints
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices ordering manual bone drills, wires, or drivers should confirm this 510(k) clearance covers the specific CMF Titanium Splints model they plan to stock.
Key points
- Materialise NV received FDA 510(k) K260913 clearance for CMF Titanium Splints as substantially equivalent under traditional review.
- The device carries product code DZJ and is classified under regulation 872.4120 for manual bone drills, wires, and drivers.
- Device class is 2, indicating moderate risk that still requires FDA marketing authorization.
Who should care
OwnerSpecialist
Read the original on openFDA Dental Devices
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