SD Implant System

The SD Implant System is a dental implant system for partially or fully edentulous patients, consisting of titanium fixtures and various abutments (healing, scan, cemented, angled, temporary, and multi-unit designs). It supports single or multiple unit restorations including cemented, screw-retained, or overdenture restorations, and can be used for two-stage or immediate-loading procedures when primary stability is adequate.

The subject device uses Pure Titanium (ASTM F67) fixtures with SLA surface treatment and internal hex anti-rotational features, with diameters of 3.3–5.0 mm and lengths of 7.0–13.0 mm. Abutments are fabricated from Ti-6Al-4V Eli (ASTM F136) and include both standard machined designs and two-piece CAD/CAM designs with zirconia superstructures. The system is compatible with previously cleared SD, NB SA, NB, and NB Mini implant systems from the same manufacturer.

ISO 14801 (static and fatigue testing of implant-abutment constructs), ISO 11137-1 and 11137-2 (sterilization validation), ANSI/AAMI ST79 and ISO 17665 (end-user sterilization), ASTM F1980 (shelf-life validation), and FDA guidance on MR environment safety. Biocompatibility of Ti-6Al-4V Eli was referenced from prior 510(k) K213506.

The subject device differs from its primary predicate (K213506) primarily in fixture diameter ranges and compatible implant system lines, but these dimensional differences are encompassed by or do not affect the fundamental function of the device. All components use identical or substantially similar materials (titanium alloys per ASTM standards), manufacturing processes (machining, SLA surface treatment, gamma sterilization), and mechanical performance criteria. Worst-case mechanical testing per ISO 14801 confirms that dimensional variations do not compromise safety or effectiveness. The indications for use and principle of operation are substantially identical, differing only in listing compatible implant systems.