Neodent InLab Validated Workflow

The Neodent InLab Validated Workflow is a digital dentistry system for designing and fabricating screw-retained multi-unit dental restorations used with the Neodent Direct Screw to Multi-Unit Abutment (MUA). It integrates intra-oral scanner files, CAD software (CARES Visual, 3Shape, or Exocad), CAM software, and milling machines (Roland and Zirkonzahn) to create personalized copings from materials including zirconia and PMMA for patients with partial or complete tooth loss.

The Direct Screw to MUA component maintains identical material (titanium alloy per ASTM F136), dimensions (2.2 mm screw head diameter, 4.1 mm total height), compatible implant connections (GM, NGM, HS), packaging, and sterilization requirements as the predicate. The key difference is the addition of the Neodent InLab validated workflow as an alternative manufacturing path for personalized copings, using specified CAD/CAM and milling equipment instead of a centralized validated milling center.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-1 (biological evaluation of medical devices), ISO 17665-1 (validation of moist heat sterilization), FDA Class II Special Controls Guidance for Root-form Endosseous Dental Implants and Abutments, and FDA Guidance on ISO 10993-1 biocompatibility evaluation.

The subject device is substantially equivalent because the Direct Screw to MUA component is identical to the predicate in material, dimensions, design, interface, packaging, and sterilization. The Neodent InLab Validated Workflow adds a new manufacturing pathway for copings with the same indications for use as the predicate. Performance testing demonstrates equal or better mechanical performance; software validation confirms accurate milling; biocompatibility, sterilization, and MRI compatibility testing support safety and effectiveness equivalent to the predicate.