Adin Long Dental Implant System

The Adin Long Dental Implant System is a titanium dental implant system intended for surgical placement in the upper jawbone to support prosthetic devices (artificial teeth) and restore chewing function in fully or partially edentulous patients. It includes Adin Touareg-OS Zygomatic Dental Implants (4.2 mm diameter, lengths 35–55 mm) for placement in the zygomatic bone in patients with severe atrophic maxilla, and angled abutments (45°–60°) for screw-retained multi-unit restorations with immediate or delayed loading.

Both subject and predicate devices use titanium alloy (Ti-6Al-4V ELI) with a resorbable blast media surface treatment for osseointegration, employ internal hex connections, are single-use screw-type implants, and support one- or two-stage surgical procedures with immediate or delayed loading. The subject device incorporates Adin's proprietary OsseoFix™ calcium phosphate RBM surface treatment (previously cleared in K212775), while the predicate uses standard RBM; both achieve comparable fatigue performance.

ISO 10993-1 and FDA guidance for biocompatibility; ISO 11137-2:2013 and ISO/TS 13004 for gamma sterilization; USP <85> for bacterial endotoxin testing; ISO 11607-1 and ISO 11607-2 for shelf-life validation; ISO 17664, AAMI TIR12, AAMI TIR30 for cleaning and steam sterilization; ISO 14801 (modified) for fatigue testing; FDA guidance on MRI safety testing.

The Adin Long Dental Implant System is substantially equivalent to the primary predicate (Noris Medical Zygomatic Dental Implants System, K151909) because both devices share identical intended use (upper jaw endosseous support for prosthetics in edentulous patients), same materials, surface technology principles, surgical approach, and support multi-unit screw-retained restorations with 45°–60° angulation. Clinical data from 36 patients with 92 abutments showed 100% success at ≥6 months, matching predicate performance; fatigue testing demonstrated comparable mechanical performance under worst-case conditions.