Preat Abutments

Preat Abutments are titanium dental abutments designed to connect endosseous dental implants to prosthetic restorations in the upper or lower jaw for single or multiple tooth replacements. The abutments are customized using CAD/CAM digital workflow and manufactured either through a validated Preat milling center or through a validated digital dentistry workflow integrating intraoral/lab scanners, CAD software, CAM software, and milling machines.

The subject device is a titanium blank abutment (Ti-6Al-4V ELI per ASTM F136) with internal implant connections compatible with 16 third-party implant systems. Design parameters include minimum wall thickness 0.5–0.9 mm, minimum post height 4.0 mm, maximum angle 30° (0° for certain systems), and gingival height 0.5–4.5 mm. The key difference from the predicate is the addition of a validated digital dentistry workflow manufacturing path alongside the previously cleared validated milling center path.

ISO 14801 (static compression and compression fatigue testing), ISO 10993-1 and ISO 10993-5 (biocompatibility), ISO 17665-1 and ISO 14937 (sterilization validation), and ASTM F136 (titanium alloy specification). MRI safety evaluation referenced FDA guidance and published literature on magnetically induced displacement force and torque.

The subject device shares identical titanium blank abutment design, materials, connection type, prosthesis attachment, and sterilization method with the primary predicate K220823. All compatible implant systems from both K220823 and K183518 are included. The only material difference is the addition of a validated digital dentistry workflow manufacturing pathway, which is supported by non-clinical bench testing, software verification (design restrictions and CAM limitation zones), and referenced to the K222044 predicate device that uses similar digital workflow technology. Design parameters, biocompatibility, and sterilization are unchanged from previously cleared submissions.