Dynamic TiBase

Dynamic TiBase is a two-piece dental implant abutment system consisting of a prefabricated titanium base (Ti-6Al-4V alloy) and a CAD-CAM fabricated zirconia superstructure. It is intended to be used with endosseous dental implants in the upper or lower jaw to support single-unit or multi-unit prosthetic restorations. The system is compatible with multiple OEM implant platforms including Osstem, Neodent, Straumann, and Nobel implants.

The subject device features a titanium base with platform diameters of 4.30–5.5 mm and gingival heights of 0.3–4.0 mm, bonded to a zirconia superstructure with minimum wall thickness of 0.20 mm and maximum angulation of 30°. It differs from the predicate K232151 in having a narrower minimum wall thickness (0.20 vs 0.32 mm), smaller maximum gingival height (6.20 vs 5.18 mm), and uses Nova Resin Cement instead of G-CEM LinkAce. The abutment screws differ in thread design and length but are otherwise materially identical.

ISO 5832-3 and ASTM F136 for titanium alloy composition; ISO 13356 for zirconia material; ISO 14801 for mechanical testing of abutments with compatible implants; ISO 10993-5 for cytotoxicity biocompatibility testing; ANSI/AAMI/ISO 17665-1 and TIR 17665-2 for moist heat sterilization validation; and FDA guidance on MRI safety for magnetically induced displacement force and torque assessment.

The subject device is substantially equivalent to predicate K232151 because both share identical intended use (support for prosthetic restorations on endosseous implants), are manufactured from the same materials (Ti-6Al-4V and zirconia) using identical processes in identical facilities, and encompass the same general dimensional ranges for platforms and gingival heights. Minor design variations (wall thickness, gingival height, cement type, screw threads) do not affect safety or effectiveness because mechanical testing per ISO 14801 demonstrates performance is maintained, and these differences are driven solely by compatible implant design requirements. The reference devices support compatibility clearances for the expanded OEM implant system list.