Dentis SQ-SL AXEL Fixture

The Dentis SQ-SL AXEL Fixture is a threaded endosseous dental implant made of pure titanium for replacing missing teeth. It is indicated for use in partially or fully edentulous mandibles and maxillae to support single or multiple unit restorations including cemented retained, screw retained, or overdenture restorations, and serves as terminal or intermediate abutment support for fixed bridgework. The system is designed for one and two stage surgical procedures with delayed loading.

The device is a root-form endosseous implant fabricated from pure titanium (ASTM F67) with an internal hex connection and SLA (sandblasted with large-grit and acid-etching) surface treatment. It comes in two configurations (Regular and Mini) with multiple diameter and length options (Regular: Ø4.2–7.0 mm × 7–17.5 mm; Mini: Ø3.8–4.2 mm × 7.5–17.5 mm). The device is sterilized by gamma irradiation and has an 8-year shelf life.

ISO 14801:2016 (fatigue testing), ISO 11137-1,2,3 (sterilization validation), ASTM F1980 (shelf-life), ISO 10993 series (biocompatibility: parts 1, 3, 5, 6, 10, 11), ANSI/AAMI ST72:2011 (bacterial endotoxin), USP <161> and <85>, and FDA Guidance for Class II Special Controls for Root-form Endosseous Dental Implants.

The subject device shares the same indications for use, design, surface treatment (SLA), material (CP titanium), sterilization method, and shelf-life as the primary predicate device K192688. The only difference is extended fixture lengths (15.5 and 17.5 mm); K140934 is cited as a reference device to demonstrate that dimension combinations cover the subject device's full range. Non-clinical testing including fatigue, biocompatibility, and sterilization validation confirms substantial equivalence.