MIS LYNX Conical Connection Implant System

The MIS LYNX Conical Connection Implant System is a dental implant device surgically placed in the upper or lower jaw bone to support prosthetic tooth replacement and restore chewing function. The submission adds two new implant sizes (4.20 mm and 5.00 mm diameter, 6 mm length) to an existing cleared product line.

The proposed implants are root-form, bone-level, self-tapping, two-piece screw-type implants made of Ti-6Al-4V ELI titanium alloy with identical manufacturing and surface treatment (anodization, sand-blasting, acid-etching) to the predicate. They feature a tapered dual-threaded design with a conical 12° implant-abutment connection (six-position anti-rotation index), cylindrical neck, micro-rings in the coronal area, and identical cover screws to the predicate. The proposed 6 mm length for these diameters matches lengths already cleared in a reference device.

ISO 14801:2016 (dynamic fatigue test for endosseous dental implants), ASTM F136-13 (titanium alloy specification), ASTM F543-23 (metallic medical bone screw test methods), ASTM F2052-21 (magnetically induced displacement force), ASTM F2213-17 (magnetically induced torque), and ASTM F2119-07 (MR image artifact evaluation).

The proposed device uses identical material, manufacturing processes, surface treatments, packaging, and sterilization as the predicate K241692. The implant-abutment connection geometry and cover screws are identical to the predicate's standard and wide platforms. The new 6 mm lengths at 4.20 mm and 5.00 mm diameters are already cleared in reference device K180282. Fatigue and pull-out testing demonstrate equivalent or superior performance compared to both predicate and reference devices. Minor design differences in micro-ring count and coronal bevel do not raise new safety or performance concerns.