Sherlock

Sherlock is a dental implant abutment system composed of prefabricated titanium base components with cemented zirconia superstructures, or pre-milled titanium blanks, or multi-unit abutments. It is designed to support single-unit or multi-unit prosthetic dental restorations on endosseous implants in the upper or lower jaw. All customizations are manufactured by Open Implants-validated milling centers.

The Subject device maintains the same material composition (Ti-6Al-4V ELI titanium and zirconia), internal engaging/non-engaging implant connection, and abutment designs (Titanium Base, Titanium Blank, and Multi-Unit configurations in straight and angulated forms) as the predicate. The primary difference is expansion to a new compatible implant system—Neodent GM with 3.0 mm platform diameter and implant body diameters from 3.5 to 7.0 mm—instead of the predicate's other implant lines.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-5 (biocompatibility cytotoxicity testing), AAMI TIR30 (cleaning validation for titanium and zirconia), ISO 17665-1 and ISO 14937 (sterilization validation), and reverse engineering compatibility analysis with OEM implant bodies.

The Subject device is substantially equivalent to the predicate because it employs identical abutment designs, materials, and manufacturing processes already cleared in prior submissions. The sole material change—compatibility with Neodent GM implants instead of other systems—is supported by reverse engineering demonstrating physical compatibility with the Neodent connection interface, and by fatigue testing per ISO 14801 confirming mechanical safety. The predicate and reference devices (K163194, K180536, K201225) already established safety and effectiveness for similar Neodent implant platforms with the same 3.0 mm diameter used here.