Bioline Dental Implant System

The Bioline Dental Implant System is a set of endosseous dental implants made from Ti-6AL-4V ELI titanium alloy, designed to be surgically placed in the upper or lower jaw to support prosthetic devices such as artificial teeth. The system includes tapered (Charanga, DACA) and cylindrical (Bolero) internal hex implants, conical implants, and numerous abutment types for single or multiple unit restorations, with certain models approved for immediate loading when primary stability is achieved.

The device features two internal hex implant designs and one conical design with matching abutments, all with grit-blasted and acid-etched (SLA) surfaces. Implants range from 3.3 to 6.0 mm diameter and 8 to 16 mm length, with pre-manufactured abutments (straight, angled up to 30°, shouldered, ball attachment, and multi-unit configurations). Interface types include internal hex and conical connections; retention caps on certain abutments support up to 20° or 14° implant divergence depending on design.

ISO 14801 (dynamic fatigue testing), ISO 10993 (cytotoxicity, skin sensitization per ISO 10993-10:2021, irritation per ISO 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, F3039-13, D5276-98, F1929-12, and F1980-07 (packaging and shelf-life).

The Bioline system is substantially equivalent to the TOV Dental Implant predicate (K240837) because both systems have identical indications for use (single/multiple unit restorations, immediate loading capability, same 3.3 mm diameter splinting requirements), use the same material (Ti-6AL-4V ELI), employ the same internal hex and conical interface designs, offer comparable abutment heights and angulations (≤30°), and demonstrate sufficient fatigue runout per ISO 14801 testing. The supporting abutment components—healing caps, straight abutments, angled abutments, ball attachments, and multi-unit configurations—are offered in materially similar designs and dimensions with equivalent performance data.