LW Pre-milled Abutment

The LW Pre-milled Abutment is a titanium dental implant abutment designed to support single or multiple tooth prostheses in patients with partial or complete tooth loss. It is customized for individual patients using CAD/CAM milling technology and is compatible with the LW Implant System and LW Narrow Implant System, accommodating both screw-retained and cement-retained restorations.

The device is fabricated from Ti-6Al-4V-ELI (ASTM F136) titanium with no surface treatment, provided non-sterile for end-user sterilization. It features hex and non-hex connection types with internal connection interfaces (2.5 mm and 2.1 mm sizes). Design specifications include gingival heights of 1.0–7.0 mm, post heights minimum 4.0 mm, and maximum angulation of 30°, with variable diameters (4.0–7.0 mm) and lengths (7.9–16.9 mm straight, 12.9–14.9 mm angled).

End-user sterilization validation per ISO 17665-1 and ISO 17665-2; fatigue testing per ISO 14801:2016; biocompatibility per ISO 10993-1:2018; MRI safety evaluation using FDA guidance on magnetically induced displacement force and torque; and FDA Class II special controls guidance for root-form endosseous dental implants and abutments.

The device is substantially equivalent to the predicate (s-Clean Pre-Milled Abutment, K210362) because both share identical indications for use, material composition (Ti-6Al-4V-ELI), surface treatment (none), sterilization method (end-user), and design methodology (patient-specific CAD/CAM customization). Although dimensional ranges and compatible implant systems differ between subject and predicate, these differences do not alter the intended use or compromise safety and performance. The implant-to-abutment compatibility and fatigue performance have been verified, and a reference device (K203344) supports the upper gingival height specification of 7.0 mm.