NobelZygoma TiUltra Implant system

The NobelZygoma TiUltra Implant system is a dental implant system designed for placement in the zygomatic bone (cheekbone) of patients with severe upper jaw bone resorption. It consists of titanium implants, multi-unit abutments, and screws that work together to support dental prostheses and restore chewing function and esthetics in patients with partial or full edentulous maxilla. The system is appropriate for immediate loading when good primary stability is achieved.

The subject implants are made of unalloyed titanium grade 4 with a two-level anodized surface and soluble salt protective layer, available in 0° and 45° angulations with lengths from 30–60 mm. Multi-unit abutments are titanium alloy (Ti-6Al-4V) with anodized Xeal surface and soluble salt coating. The implants introduce a modified surface topography compared to earlier NobelZygoma models and a more compact implant mount design. The 0° variant features a conical connection (similar to Reference Device #7) while the 45° variant retains external hex connection.

ISO 14801 (adapted for zygomatic implants), ISO 10993-1 series (biocompatibility), ISO 11607-1/2 (packaging), ASTM F2052-21, ASTM F2213-17, ASTM F2182-19e2, ASTM F2119-24 (MR safety), ISO 11137-1/2/3 (sterilization validation), ASTM D4169, ASTM F1886, ASTM F2096 (packaging performance), ASTM F1980 (shelf-life), FDA Guidance on Class II Special Controls for endosseous dental implants and MR device safety.

The subject device shares the same fundamental design, intended use, material composition, and surface treatment (anodic oxidation with soluble salt layer) as the primary predicate (NobelZygoma 45° TiUnite). Although the subject introduces minor modifications—including a two-level surface topography instead of single-level, different implant mount design, extended length range to 60 mm, and new abutment height variants—these do not raise different questions of safety and effectiveness. Worst-case fatigue testing demonstrates equivalent or superior performance to predicate devices. Post-market surveillance data and extensive clinical literature on similar zygomatic systems show comparable implant survival rates (>90%) with no new adverse events. The modified surface roughness and protective salt layer are supported by clinical data on comparable machined versus anodized collar designs and the established TiUltra implant family performance.