Medentika CAD/CAM Abutments

Medentika CAD/CAM Abutments are dental implant abutments made of titanium alloy (Ti-6Al-4V ELI) used to support single or multiple tooth prostheses in patients with partial or complete tooth loss. The abutments can be manufactured either through a digital dentistry workflow (using CAD/CAM software, intraoral and desktop scanners, and milling machines) or at an FDA-registered validated milling center. Zirconia superstructures are cemented onto titanium bases to create the final restoration.

The subject device uses the same titanium alloy material (Ti-6Al-4V ELI per ASTM F136) and identical abutment designs as previous Medentika submissions. It differs from predicate K221301 in allowing manufacturing via digital dentistry workflow rather than only through validated milling centers. Compatible implant diameters range from 3.0–8.0 mm (adding 8.0 mm compatibility). Zirconia superstructures have minimum wall thickness of 0.5 mm, minimum cementable post height of 4.0 mm, and maximum angulation of 30°. Bonding is performed with Multilink Hybrid Abutment Cement (K130436).

ISO 10993-1, ISO 10993-5, and ISO 10993-12 (biocompatibility testing); ISO 14801 (mechanical fatigue testing); ISO 17665-1 and ISO TR 17665-2 (moist heat sterilization validation to 10⁻⁶ sterility assurance level); ASTM F136 (titanium alloy specification for surgical implants).

The subject device is substantially equivalent to predicate K221301 because both are intended for dental implant abutment restoration using identical materials (Ti-6Al-4V), same design principles, and equivalent design parameters (wall thickness, post height, angulation limits). The key difference—allowing digital dentistry workflow manufacturing in addition to validated milling centers—does not raise different safety or effectiveness questions because software validation demonstrates design parameter constraints are enforced, mechanical testing confirms structural integrity with compatible implants, and CAM software validation ensures manufacturing accuracy. New implant compatibilities (Neodent GM, Straumann BLX/BLC RB/WB, MegaGen AnyRidge) are supported by reverse engineering analysis and fatigue testing of worst-case constructs, demonstrating compatibility without changing the fundamental abutment design or materials.