Adin Customized Abutments

Adin Customized Abutments are dental implant abutment components designed for use with Adin dental implants in patients with missing teeth (partial or full). They support single or multiple tooth restorations that are either screw-retained or cement-retained. The abutments are manufactured using digital dentistry workflow—combining intraoral/desktop scanners, CAD/CAM software, and milling machines—and are provided non-sterile for user sterilization.

Two main component types: Ti-bases (titanium bases with cementing surfaces for zirconia superstructures) and Ti-blanks (titanium blanks milled to patient-specific abutments). Both use titanium alloy Ti-6Al-4V ELI. Zirconia superstructures (ArgenZ Ultra) are cemented with Panavia V5. Design parameters include wall thickness ≥0.5 mm for Ti-bases and ≥0.7 mm for some Ti-blank variants; gingival heights from 0.65–4.0 mm; and maximum angulation up to 20–25° depending on implant type. Compatible with Adin implants via internal hex or conical connections.

ISO 14801 (mechanical testing); ISO 17665-1 and ISO 17665-2 (steam sterilization validation to 10⁻⁶ SAL); ISO 10993-5 Annex C (MTT biocompatibility); ISO 10993-1 and ISO 10993-12 (general biocompatibility); ASTM F136 (titanium alloy specification); FDA guidance on MRI safety (magnetically induced displacement force and torque).

The subject device is substantially equivalent to primary predicate K221301 (DESS Dental Smart Solutions) based on identical intended use, digital dentistry workflow, CAD/CAM design principles, and abutment designs. It is also equivalent to reference devices K223714, K112585, and K081751 for titanium component design, materials (Ti-6Al-4V, zirconia, Panavia V5 cement), sterilization method (moist heat), and implant interface connections. Titanium and zirconia biocompatibility is supported by reference device K223714 testing and validated digital dentistry workflow testing per ISO 10993 standards.