NizPlant Dental Implant System

The NizPlant Dental Implant System is a root-form endosseous dental implant for surgical placement in edentulous or partially edentulous mandibles and maxillae. It supports complete denture prostheses, fixed or removable bridgework, and overdentures. The system includes one- or two-piece implant assemblies, abutments, and other restorative components, with support for immediate function when primary stability is achieved.

The NizPlant implant features a titanium alloy (Ti-6Al-4V ELI) threaded body with double-lead reverse buttress threads and two cutting grooves. Body diameters range 3.0–5.7 mm and lengths 7–14 mm. The implant has a 2mm machined straight neck anodized gold, a 2.5 mm internal hex connection, and a blasted microtextured surface. Key differences from the predicate: larger body diameters (up to 5.7 mm vs. 4.7 mm), shorter lengths (7 mm vs. 8 mm minimum), and indication for short implants in limited bone volume.

ISO 10993 and ISO 7405 (biocompatibility); ANSI/AAMI/ISO 11137-2 (sterilization validation); ISO 17664-1, AAMI TIR12, and ISO 17665 (cleaning and sterilization for non-sterile devices); ASTM F2052, F2119, F2182, F2213 (MRI safety); ASTM F1980-21 (accelerated aging); ASTM D4169 and F7386 (simulated transportation); ANSI/AAMI ST72:2019 and USP <161>, <85> (endotoxin testing); ASTM F136-13 (titanium material specification).

The subject device and primary predicate (K090234) share the same general design, platform, cutting flutes, sterilization method, materials, and surface treatment. Both are threaded root-form titanium implants supplied sterile with gamma irradiation, intended for single-stage surgical implantation supporting various restorations with immediate function capability. Minor differences in body diameter and length ranges, and the addition of a short implant indication for limited bone volume, do not change the fundamental intended use or technological characteristics, supporting substantial equivalence.