Geo Abutment

The Geo Abutment is a titanium base abutment system designed to support prosthetic devices in partially or completely edentulous patients. It includes two product types: Multibase (a two-piece abutment with a zirconia superstructure cemented on top) and CMFit (a machinable blank for CAD/CAM fabrication of all-titanium patient-specific abutments). Both are intended for single-unit or multi-unit cement-retained prostheses in the mandible or maxilla, compatible with seven implant systems from four manufacturers.

Geo Abutment Multibase is titanium alloy (Ti-6Al-4V) with titanium nitride (TiN) coating, restricted to straight designs only (0° angulation), with zirconia superstructures meeting ISO 13356. CMFit is cylindrical titanium blank available in two diameters (9.9 mm or 13.9 mm) for milling to up to 30° angulation. The primary predicate (K182246) Multibase (L-Link) allows up to 20° angulation, while CMFit matches the predicate's 30° capability. Both use 3M ESPE RelyX Unicem bonding cement and are provided non-sterile, sterilizable by moist heat.

ISO 14801 (dynamic fatigue test for endosseous dental implants); ISO 17665-1 and ISO 17665-2 (sterilization validation); ISO 13356 (yttria-stabilized tetragonal zirconia material for implants); ASTM F1044 and F1147 (shear and tension testing of coated surfaces); ISO 10993-5 and ISO 10993-12 (biocompatibility); ASTM F136 (titanium alloy material specification).

The subject device is substantially equivalent because it shares the same intended use (supporting prostheses in edentulous patients), basic design principles (CAD/CAM-based titanium abutments), and materials (titanium alloy with TiN coating and zirconia superstructures) as the predicate K182246. Although the Multibase is restricted to straight designs (0°) versus the predicate's 20° capability, this represents a narrower, more conservative design that does not compromise safety or effectiveness. Differences in compatible OEM implant systems and platform diameters are related only to different implant manufacturers and are mitigated by ISO 14801 fatigue testing demonstrating sufficient strength. The CMFit matches the predicate's up to 30° angulation capability and design parameters, differing only in implant compatibilities which testing confirms are adequate.