ALLONUS Tech Prosthetics

The ALLONUS Tech Prosthetic is a dental implant abutment made of titanium alloy (Ti-6Al-4V ELI) designed to support single or multiple-unit prosthetic restorations in the upper or lower jaw of partially or fully edentulous patients. It is compatible with numerous implant systems and can be used for cemented-retained, screw-retained, or overdenture restorations. The device consists of pre-milled blanks, titanium bases, and multi-unit components that are either pre-manufactured or customized via CAD/CAM milling.

The subject device is substantially the same material (Ti-6Al-4V ELI, ASTM F136) and construction as predicate devices, with no surface treatment. Design limits are slightly different (e.g., gingival height 0.5–5.0 mm vs. predicate 0–30°), but fall within the diameter and angle ranges of predicates. The multi-unit components have marginally larger diameters (e.g., 5.1 mm vs. 4.8 mm) and slightly different gingival height ranges, but these variations do not affect intended function.

ISO 14801:2016 (fatigue testing), ISO 17665-1:2006 and 17665-2:2009 (steam sterilization), ANSI/AAMI ST79:2010 (sterilization), ISO 10993-1:2009, ISO 10993-5:2009, and ISO 10993-10:2010 (biocompatibility), plus FDA Guidance on Class II root-form endosseous dental implants and abutments.

The subject device shares identical material composition, lack of surface treatment, and similar indications for use with multiple predicate devices (Medentika CAD/CAM Abutment, TiGEN Abutment, TruAbutment DS, and Nobel Active Multi Unit Abutment). Although design parameter ranges differ slightly (e.g., gingival height or diameter), the subject device's dimensions remain within or overlap the predicates' ranges, and reverse engineering demonstrated implant-to-abutment compatibility. Non-clinical testing including fatigue, sterilization, and biocompatibility testing confirmed performance equivalent to predicates, and these minor dimensional variations do not alter the device's intended use or clinical function.