Neodent Implant System - Zirconia Implant System

The Neodent Implant System - Zirconia Implant System is a set of endosseous dental implants and abutments made from zirconia (Y-TZP) intended for surgical placement in the jaw bone to support prosthetic dental restorations (crowns, bridges, dentures). The system includes implants in bone-level and tissue-level configurations, temporary healing abutments, cover screws, and permanent prosthetic bases, all designed for single or multiple tooth replacement with immediate or conventional loading protocols.

The subject devices are manufactured from yttrium-stabilized zirconia dioxide (Y-TZP) with a 5.0 mm diameter and lengths ranging from 5 to 13 mm, depending on configuration. They feature a straight internal connection with indexing features (Zilock) matching the predicate devices, cylindrical or tapered body geometry with trapezoidal thread profiles, and are provided sterile via ethylene oxide to a SAL of 1×10⁻⁶. The abutments are two-piece designs with cementable portions and multiple gingival height options for customization.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-1 (biological evaluation of medical devices), ISO 10993-5 (cytotoxicity), ISO 10993-18 (chemical characterization), ISO 11135:2014 (ethylene oxide sterilization), ISO 17665-1 (moist heat sterilization), ASTM F136 (titanium alloy specification), ANSI/AAMI ST72:2011 (bacterial endotoxin test), and US Pharmacopeia Chapter 85.

The subject devices are substantially equivalent to predicate K201491 because they share identical indications for use, raw material composition (Y-TZP zirconia), implant-abutment connection design (Zilock), overall geometry, sterilization method, and manufacturing processes as the predicate. Bench testing (dynamic fatigue, torsion, insertion torque, surface analysis) demonstrated performance equivalent to predicates under identical test conditions. Clinical literature review showed zirconia and titanium implants achieve similar osseointegration outcomes. The addition of a 5 mm length implant option and new abutment variants represents a portfolio expansion using established technology, not a change in fundamental design or mechanism.