OsseOne Dental Implant System

The OsseOne Dental Implant System is an endosseous (bone-embedded) dental implant system designed to be surgically placed in the upper or lower jaw to support prosthetic devices such as artificial teeth. It restores patient esthetics and chewing function and can be used for single or multiple tooth restorations with immediate or conventional delayed loading.

The system includes internal hex and conical implant designs made from Ti-6AL-4V ELI with grit-blasted and acid-etched surfaces. It offers multiple implant diameters (NP 3.5mm, RP 4.3–5.5mm) and lengths (8–16mm), along with compatible abutments including straight, anatomic, angled, and multipurpose indexed variants. Healing caps, cover screws, multi-unit abutments, and ball/denture lock attachments with polyamide or polyether retention caps are included.

ISO 14801 (dynamic fatigue testing), ISO 10993 series (cytotoxicity, skin sensitization, irritation per ISO 10993-10:2021 and 10993-23:2021), ISO 17665-1 (steam sterilization validation), ISO 11137-2 (gamma irradiation validation), ANSI/AAMI ST72:2019 and USP <161> (bacterial endotoxin), ASTM D999-08, ASTM F3039-13, ASTM D5276-98, ASTM F1929-12, ASTM F1980-07 (package and shelf life testing).

The OsseOne system is substantially equivalent to the OsseoPlus/OsseoLock predicate because both share identical indications for use, the same Ti-6AL-4V ELI material with SLA surface treatment, and comparable implant/abutment designs with adequate fatigue performance demonstrated by ISO 14801 testing. Minor design differences in implant geometry and thread profiles are bridged by showing both systems achieve sufficient run-out loads for their intended use. The abutment designs are substantially similar in form and function to predicate comparators (TOV and Surgikor systems), all using conical connections with proven biocompatibility data leveraged from prior clearances.