SD TL Implant System

The SD TL Implant System is an endosseous (bone-anchored) dental implant system used to replace missing teeth in the upper or lower jaw. It consists of titanium implant fixtures and custom-milled abutments (connector pieces) that support single or multiple artificial tooth restorations, including crowns, bridges, and dentures. The system supports both traditional delayed loading and immediate loading when bone stability permits.

The implant fixture is made of pure titanium (ASTM F67) with an SLA (sandblasted and acid-etched) surface treatment and a 1.5 mm gingival height. The abutment is titanium alloy (Ti-6Al-4V Eli, ASTM F136) in a square-connection design with diameters ranging from 3.7–5.0 mm and lengths from 7.0–13.0 mm. It is a tissue-level (rather than bone-level) implant with a non-submerged external connection, sterilized by gamma irradiation or user steam sterilization.

ISO 14801 (static and fatigue mechanical testing), ISO 11137-1 and 11137-2 (sterilization validation), ANSI/AAMI ST79 and ISO 17665 (end-user sterilization), ISO 11737 (sterilization validation), ISO 11138-1 (biological indicators), AAMI/ANSI ST72 (LAL endotoxin), ASTM F1980 (shelf-life accelerated aging), and FDA guidance on MR environment safety.

The subject device is substantially equivalent because it has the same intended use, materials (titanium alloys), sterilization methods, and functional design as the primary predicate (Osstem SSIII SA). Although the subject device offers a narrower diameter range (3.7–5.0 mm vs. 4.8–6.0 mm), this gap is bridged by reference predicates with wider size ranges. The square connection differs from the predicate's internal hex, but mechanical testing per ISO 14801 confirmed comparable performance. All critical technological characteristics—material composition, surface treatment, gingival height, operational principle, and indications—align with the predicates, and non-clinical testing demonstrates equivalent safety and effectiveness.