iPhysio® System

The iPhysio® System is a two-piece titanium healing abutment (Profile Designer) with a zirconium nitride coating, designed to be screwed into dental implants immediately after placement to protect the implant's internal configuration and maintain soft tissue during healing for up to 6 months. It is compatible with Nobel Biocare, Straumann, and Zimmer Biomet implant systems. An optional PEEK temporary abutment clips onto the Profile Designer to support a temporary crown out of occlusion.

The subject device differs from the predicate (Straumann Ceramic Healing Abutments K192853) in three minor ways: it includes a ZrN coating (similar to reference K212628), offers four anatomical abutment shapes rather than circular only, and is compatible with multiple OEM implant systems rather than Straumann alone. All differences maintain internal screw-retained connection, straight 0° angle, titanium alloy construction, and non-load-bearing function.

ISO 5832-3 (titanium alloy material), ISO 10993 series (biocompatibility: cytotoxicity, sensitization, irritation, acute toxicity, pyrogenicity, implantation, genotoxicity/carcinogenicity), ISO 11137-2 (gamma sterilization validation to SAL 10⁻⁶), ISO 17665-1 (steam sterilization), ISO 11607-1 (shelf-life validation), ISO 14801:2016 (fatigue testing for temporary abutments), ASTM F2026 (PEEK material), ASTM F2503-20 (MR compatibility).

The subject device is substantially equivalent because its intended use—protecting the implant and forming soft tissue during healing for up to 6 months—is identical to the predicate and reference devices. Technologically, all are screw-retained, non-load-bearing healing abutments with similar materials (titanium). The ZrN coating is supported by characterization testing and was used in reference K212628. Multiple anatomical shapes and OEM compatibility are confirmed via reverse engineering analysis without raising safety or effectiveness concerns. Non-clinical testing including biocompatibility, sterilization validation, and fatigue testing all passed acceptance criteria.