NUVENTUS NV.C™ Prosthetic Components

NUVENTUS NV.C™ Prosthetic Components is a portfolio of endosseous dental implant abutment components used to restore fully or partially edentulous patients. The portfolio includes healing components (protect implant inner configuration during healing up to 180 days), temporary prosthetic components (maintain soft tissue contour during healing, also up to 180 days and not in occlusion), multi-unit abutments (provide support structure for bridges or full-arch prostheses), and final prosthetic copings (connected to implants via abutments for final bridge or full-arch rehabilitation).

All components are manufactured from titanium alloy Ti-6Al-4V ELI (ASTM F136). They feature conical connection interfaces (NP and RP platform sizes), come in various body diameters (3.4–5.5 mm), transmucosal heights (1.5–5.0 mm), and angulations (0°, 17°, 30°). Healing and multi-unit abutment components are gamma-irradiated sterilized; temporary and final components are delivered non-sterile for steam sterilization before clinical use.

ISO 14801:2016 (mechanical testing of implant abutments), ISO 10993-5 (cytotoxicity biocompatibility), ISO 11137-1 and ISO 11137-2 (gamma irradiation sterilization validation to 10⁻⁶ SAL), ISO 17665 (steam sterilization validation), ASTM F1980 (accelerated aging and shelf-life testing), ANSI/AAMI ST72 (bacterial endotoxin testing), and FDA guidance on MRI safety assessment.

The subject device and predicates (Nobel Biocare healing abutments, Straumann temporary abutments, Nobel Biocare multi-unit and clinical screws, and Straumann final copings) share identical intended uses (supporting temporary and final prosthetic rehabilitation), identical materials (titanium ASTM F136), identical sterilization methods (gamma irradiation or steam sterilization per protocol), same product code (NHA), and overlapping or equivalent physical dimensions and interface platforms. Non-clinical testing (mechanical, biocompatibility, sterilization validation) demonstrates functional and safety equivalence, and no clinical data was required because the indications for use are substantially equivalent to already-cleared predicates.