MIST IC

The MIST IC is a line of titanium-based and machinable blank dental implant abutments designed to support prosthetic devices in patients with missing teeth. The abutments interface with compatible dental implants from four manufacturers (Straumann Bone Level, Straumann Tissue Level, Straumann BLX, and Neodent GM) and are customized using CAD-CAM technology at Imagine Milling Technologies validated milling centers. They support single-unit or multi-unit, cement-retained prostheses in the mandible or maxilla.

The subject device includes two abutment types: L-LINK (titanium base with titanium nitride coating) and PREFIT (machinable titanium blank). Both are made from titanium alloy (ASTM F136) with identical materials, manufacturing processes, and sterilization methods to the predicate K222368. Key differences from the predicate are expanded prosthetic platform diameters (3.8–6.9 mm versus 3.4–6.0 mm) and increased maximum gingival height for Straumann BLX L-LINK abutments (6.0 mm versus 5.0 mm), but these differences relate to compatible OEM implant designs rather than fundamental device characteristics.

ISO 14801 (static and dynamic compression-bending testing), ISO 17665-1 and ISO 17665-2 (sterilization validation), ISO 10993-1 (biocompatibility), ISO 13356 (zirconia copings), ASTM F136 (titanium alloy specification), ASTM F1044 and F1147 (shear and tension testing of TiN coating). MR safety analysis referenced FDA guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment (October 2023).

The subject device is substantially equivalent to predicate K222368 because both share the same intended use (supporting dental prostheses), identical materials and manufacturing processes, and the same abutment design philosophy (CAD-CAM customization). Dimensional differences in platform diameters and gingival heights are driven by OEM implant body compatibilities rather than design changes to the abutment itself. ISO 14801 mechanical testing of subject device constructs demonstrates these dimensional variations do not compromise safety or effectiveness. The TiN coating process is identical to the predicate, and sterilization and biocompatibility data are directly referenced from previously cleared devices.