SD TL Implant System

The SD TL Implant System is a dental implant system used to replace missing teeth in partially or fully edentulous patients. It consists of titanium fixtures (implants placed in bone), titanium alloy abutments, and zirconia superstructures for single or multiple-unit restorations. The system supports cemented, screw-retained, or overdenture restorations and is designed for two-stage surgical procedures with capability for immediate loading when primary stability is adequate.

The subject device includes SD Tissue Level and SD Bone Level fixtures made of pure titanium (ASTM F67) with SLA surface treatment, and abutments made of Ti-6Al-4V ELI (ASTM F136). Key variants include Multi Angled Cylinders (15° angulation), Multi Digital and Multi Ti Cylinders (two-piece designs with CAD/CAM zirconia superstructures), healing caps, healing abutments, and temporary abutments. The system is compatible with multiple implant lines and provides a range of diameters and lengths to accommodate various clinical situations.

ISO 14801 (mechanical performance testing), ISO 10993-5 and ISO 10993-12 (biocompatibility), ISO 11137-1 and ISO 11137-2 (sterilization validation), ANSI/AAMI ST79 and ISO 17665 (end-user sterilization validation), ASTM F1980 (shelf-life validation using accelerated aging), AAMI/ANSI ST72:2011 (LAL endotoxin testing), and scanning electron microscopy/energy dispersive X-ray spectroscopy (surface characterization).

The subject device shares identical intended use, materials (titanium and zirconia), sterilization methods, and design principles with its primary predicate K242753. Dimensional differences in cuff lengths and compatible implant ranges are supported by reference devices that encompass these size variations, demonstrating that such variations do not affect fundamental function or safety. Mechanical performance testing per ISO 14801 confirms worst-case constructs meet performance standards identical to predicates, and biocompatibility and sterilization validation data using identical materials and processes support equivalence.