Custom Abutments

The Straumann Custom Abutments are patient-matched dental implant abutments used to restore Straumann dental implants for single tooth replacement and multiple tooth restorations with cemented prosthetic restorations. The abutments are custom-designed using CAD/CAM software and manufactured at Straumann-validated milling centers. This submission adds the capability to design and manufacture abutments with angled screw channels (up to 20° screwdriver angulation) in addition to the existing straight screw channel options.

The Custom Abutments feature multiple implant-to-abutment connection geometries (SynOcta, CrossFit, and TorcFit) compatible with various Straumann implant systems across implant body diameters of 3.3–6.5 mm. They are manufactured from titanium alloy (Ti6Al7Nb per ISO 5832-11) or commercially pure titanium (ISO 5832-2), supplied non-sterile for end-user steam sterilization, and support gingival heights from 0–4.6 mm with minimum wall thickness to screw channel of 0.5 mm. The key addition is support for angled screw channels up to 25° from the knee point, compared to straight channels in the predicate.

ISO 14801:2016 (dynamic loading test for endosseous dental implants), ISO 5832-11:2014 and ISO 5832-2:2018 (metallic materials for implants), ISO 17665-1 and ISO/TS 17665-2 (steam sterilization validation), ISO 10993-1 (biocompatibility evaluation), ASTM F2052-15, ASTM F2213-06, ASTM F2182-11a, and ASTM F2119-13 (MRI compatibility).

The Custom Abutments are substantially equivalent because they use identical materials, manufacturing processes at Straumann-validated milling centers, sterilization methods, and connection geometries to the predicate K200586 and reference devices. The addition of angled screw channel capability (up to 20° screwdriver angulation) does not raise different safety or effectiveness questions because dynamic fatigue testing per ISO 14801 on worst-case constructs demonstrated adequate performance. The increased minimum wall thickness to screw channel (0.5 mm vs. 0.33 mm in predicate) further supports safety. All other design parameters, materials, indications for use, and intended patient populations remain equivalent to cleared predicate devices.