Solidex® Ti-Links and Screws

Solidex® Ti-Links and Screws is a two-piece endosseous dental implant abutment system consisting of a titanium base component and a CAD/CAM-designed zirconia superstructure, used with dental implants in the upper or lower jaw to support prosthetic tooth restorations. The zirconia crown portion is custom-milled either at a validated milling center or point-of-care using digital dentistry workflow (intraoral/lab scanners, CAD/CAM software, milling equipment).

The subject device uses machined titanium alloy (Ti-6Al-4V ELI, ASTM F136) without surface treatment, whereas the predicate device has anodization and SelectGrip® surface treatment. Both use identical zirconia superstructure material (Y-TZP). The digital manufacturing workflow differs in equipment and software vendors (PrograMill Dry vs. VHF R5), but design workflows are substantially similar. Platform sizes range from Ø2.8mm to Ø5.7mm with maximum 20° angulation.

ISO 10993-1:2018 (biocompatibility); ISO 10993-5:2009 (cytotoxicity); ANSI/AAMI ST79:2017 with amendments (moist heat sterilization validation); ISO 17665:2024, ISO 11138-1:2017, ISO 11138-3:2017, ISO 11737-1:2018, ISO 11737-2:2019, ISO 11140-3:2007 (sterilization process validation); ISO 14801:2016 (mechanical fatigue testing); ASTM F136 (titanium alloy specification).

The subject device is substantially equivalent to predicate K240982 because it has identical indications for use (supporting prosthetic restorations with endosseous implants), identical product codes (NHA, PNP), and substantially equivalent design (CAD/CAM bases, cement/screw retention, identical abutment materials). Minor differences in surface treatment and manufacturing equipment vendors do not affect substantial equivalence. Non-clinical testing (biocompatibility, sterilization validation, mechanical testing, software verification) confirms the device meets applicable standards.