Straumann InLab Validated Workflow

The Straumann InLab Validated Workflow is a digital CAD/CAM system for designing and fabricating patient-specific dental abutment restorations milled from pre-milled titanium blanks. The workflow integrates intraoral scanners, 3Shape CAD software, CAM software, a Roland DWX-42W Plus milling machine, and pre-milled abutment blanks to produce custom restorations for single or multiple tooth implant-supported prosthetics in partially or fully edentulous patients.

The proposed device uses 3Shape Abutment Designer CAD software (versus Straumann CARES Visual in the predicate), accepts STL files from multiple scanner brands (3Shape Trios, Allied Star SIRIOS, Medit T500), employs encrypted CAM file transfer to ensure only validated configurations are milled, and uses a Roland DWX-42W Plus milling machine for wet milling of titanium blanks. It supports both Straumann and Neodent pre-milled abutment blanks with titanium alloy materials, design constraints (minimum 4 mm post height, 30° maximum angulation, 0.5 mm minimum wall thickness), and compatible implant interfaces.

ISO 17665-1 for sterilization validation; ISO 10993-1 for biocompatibility assessment; FDA guidance on root-form endosseous dental implants and abutments for dynamic fatigue and performance testing; ISO standards for milling accuracy validation and simulated use testing to confirm workflow restrictions and design constraints are properly implemented in the software.

The proposed device is substantially equivalent because it uses the same fundamental technology, materials, and manufacturing principles as the predicate K171649 (Straumann CARES M-Series CADCAM System). Both systems employ optical scanning, CAD/CAM design and fabrication, encrypted file transfer to restrict milling to validated configurations, and produce patient-specific abutment restorations from titanium blanks. The primary difference—use of 3Shape CAD software instead of proprietary Straumann software—does not raise new safety or effectiveness questions, as demonstrated by equivalent testing for milling accuracy, implant-abutment connection integrity, sterilization, biocompatibility, and material properties. The validated workflow restrictions, design constraints, and encrypted file protection ensure consistent, safe, and effective performance across both Straumann and Neodent abutment blank platforms.