IPD Dental Implant Abutments

IPD Dental Implant Abutments is a system of dental abutments, screws, and accessories designed to connect dental implants to prosthetic restorations (crowns or bridges) in the upper or lower jaw. The system includes multiple abutment types (titanium bases, multi-unit, overdenture, temporary, and healing abutments) compatible with various commercially available implant systems, and uses a digital dentistry workflow for designing custom zirconia superstructures.

The subject device uses titanium alloy (ISO 5832-3) with TiN or anodized coatings for abutments and screws, identical to the predicate. It encompasses the same five abutment design categories, supports internal and external connections, accommodates platform diameters from 3.0–6.5 mm, permits maximum abutment angulation of 30°, and is provided non-sterile for end-user steam sterilization. The primary distinction is expanded compatibility with additional third-party implant systems (Straumann Tissue Level, Straumann Bone Level, Zimmer Tapered Screw-Vent, and others) and new angulation options specific to each system.

ISO 5832-3 (titanium alloy materials), ISO 17665-1 (sterilization validation), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 14801 (static and dynamic fatigue testing of implant/abutment configurations), and FDA Class II Special Controls Guidance for Root-form Endosseous Dental Implants and Abutments. MRI safety evaluation referenced published literature on magnetically induced displacement force and torque.

The subject device is substantially equivalent because it has identical intended use, materials, and sterilization methods as the primary predicate (K242819). Both employ the same titanium alloy composition, identical abutment design categories, and identical surface coatings and fabrication processes. The subject device's expansion to new compatible implant systems represents a logical extension of an already-cleared modular system, with compatibility validated through reverse engineering and dimensional analysis. Non-clinical testing (fatigue, biocompatibility, sterilization validation) demonstrates performance parity, and the digital dentistry workflow (scanner, CAD/CAM software, zirconia material, milling machine) remains unchanged from the predicate.