Customized Abutment and Screw

The Customized Abutment and Screw is a dental implant component composed of a titanium abutment and screw. It connects, supports, and retains dental restorations on implants placed in the jawbone after tooth loss, indicated for single-unit restorations only. All digitally designed abutments are manufactured at a BESMILE-validated milling center.

The device uses Ti-6Al-4V (abutment) and Ti-6Al-4V ELI (screw) titanium alloys per ASTM F1472 and F136, with untreated surfaces, internal connection type, and single-use non-sterile delivery. It is sterilized by steam sterilization. Key differences from the predicate include a narrower diameter range (4.0–6.5 mm vs 3.3–6.0 mm) and expanded transgingival height (1–5 mm vs 0.5–4.0 mm), though post height remains within predicate range.

ISO 14801:2016 (dynamic loading test for endosseous dental implants) for static and dynamic fatigue testing; ISO 10993-1 and ISO 10993 series for biocompatibility evaluation; FDA Guidance for Class II Special Controls (root-form endosseous dental implants and abutments); FDA guidance on MR environment safety testing.

Although the subject device differs from the predicate in compatible implant systems, diameter range, and transgingival height, fatigue testing demonstrated the worst-case design has sufficient strength for intended clinical use. Since substantial equivalence compares device similarity rather than implant compatibility, and the subject device's narrower indications (single-unit only) are a subset of the predicate's broader use, the devices are substantially equivalent in design, materials, and safety profile.