IPD Dental Implant Abutments

IPD Dental Implant Abutments are components that attach to endosseous dental implants in the upper or lower jaw to support single or multiple tooth prosthetic restorations. The system includes titanium-based abutments (Ti Base Interface, Multi-Unit, and Overdenture designs), titanium screws with various coatings, and integrates with a digital dentistry workflow for designing and fabricating zirconia superstructures.

Subject device uses titanium alloy (ISO 5832-3) with TiN coating for abutments and screws, identical to the primary predicate. It includes three abutment categories (Ti Base Interface, Multi-Unit, Overdenture) compatible with 18+ commercial implant systems, with platform diameters ranging 3.0–5.7 mm and maximum angulation of 30°. The Ti Base workflow employs 3Shape Abutment Designer Software (K151455) and DD Bio Z zirconia (K142987), matching predicate specifications.

ISO 17665-1 (sterilization validation to SAL 1×10⁻⁶), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 14801 (static and dynamic fatigue testing), ISO 5832-3 (titanium alloy material specification), and FDA Class II Special Controls Guidance for endosseous dental implants and abutments.

The subject device is substantially equivalent because it maintains identical intended use, materials (Ti alloy + TiN coating), sterilization methods, and fabrication processes as the primary predicate (K240570). Non-clinical testing demonstrates equivalent performance across all device categories. While the submission adds Multi-Unit and Overdenture abutment designs and expands compatible implant systems, these are design variations within the same functional category and do not introduce new safety or efficacy concerns; the digital workflow validation and fatigue testing confirm performance parity with predicate.