IPDmilled Blanks

IPDmilled Blanks are dental implant abutments (connector pieces) made of titanium alloy that attach to endosseous dental implants to support prosthetic tooth restorations. The abutments are customized using digital design software and computer-aided milling, then sterilized by the end user before placement in the maxillary or mandibular arch.

The subject device uses titanium alloy Grade 5 (ISO 5832-3) material with straight abutments (0° angle), compatible with implant diameters of 3.0–7.0 mm platform diameters. It employs a digital dentistry workflow with 3Shape scanners and design software, CORiTEC milling machines, and has design parameters including minimum gingival height of 0.5 mm, maximum of 6.0 mm, minimum wall thickness of 0.4 mm, and minimum post height of 4.0 mm. The predicate device has similar materials and workflow but allows up to 30° abutment angles and slightly smaller platform diameters (2.52–6.5 mm).

ISO 5832-3 (titanium alloy material), ISO 17665-1 (sterilization validation for SAL 1×10⁻⁶), ISO 10993-5 (cytotoxicity testing), and FDA Guidance on MRI safety testing for magnetically induced displacement force and torque.

The subject device is substantially equivalent because it has identical intended use (supporting prosthetic restorations on endosseous implants), same material composition (titanium Grade 5), similar design principles (customized abutments fixed with screws), equivalent digital workflow and manufacturing processes, and identical sterilization methods to the primary predicate device K240982. Performance testing demonstrates the device meets applicable specifications without raising safety or efficacy concerns.