MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System

MIS Implant Systems are sterile titanium dental implants designed to be surgically placed in the upper or lower jawbone to support artificial teeth and restore chewing function. They are supplied with cover screws and can be immediately loaded under certain conditions (good primary stability and appropriate occlusal load). Narrow implants (3.3mm diameter) have restricted use to specific anterior tooth regions and must be splinted if multiple implants are placed adjacent to each other.

The subject devices use titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) with unchanged implant and cover screw design. Minor changes were made to primary packaging dimensions (inner tube dimensions, cap, and titanium stage/ring design) for both Dry and CLEAR configurations, while secondary packaging (blister pack with Tyvek) and tertiary packaging (cardboard box) remain identical to the predicate. All devices maintain the same sterilization method (gamma irradiation), SAL (10⁻⁶), and 1-year shelf life as the predicate.

ISO 10993-1 (Biocompatibility), ISO 11737-1:2018 (Sterilization—microbiological methods), ASTM D4169-22 and D4332-22 (Transportation testing), ISO 11607-1:2019 (Packaging for sterilized devices), ASTM F1929-15 (Seal leak detection), ASTM F88/F88M-23 (Seal strength), ASTM F2096-11 (Gross leak detection), ASTM F1980-21 (Accelerated aging), ISO 11737-2:2019 (Sterility testing), ISO 14801:2016 (Fatigue testing), ASTM F2052-21 and F2119-07 (MR safety testing).

The subject devices have identical intended use, indications, implant design, and material composition to the predicate (MIS LYNX Conical Connection K241692). The only change is minor modification to primary packaging dimensions with no change to packaging materials or performance specifications; hydrophilicity testing confirmed the CLEAR configuration maintains super-hydrophilic surface requirements over shelf life. Since packaging changes do not affect implant safety or function and all devices perform to identical specifications, the minor packaging differences do not raise new safety or effectiveness questions compared to the predicate.