MegaGen Dental Implant Abutment

The MegaGen Dental Implant Abutment is a portfolio of endosseous dental abutments intended to be surgically placed in the maxillary or mandibular areas to provide prosthetic support for dental restorations (crowns, bridges, overdentures) in partially or fully edentulous patients. The portfolio includes healing abutments, temporary cylinders, cast abutments, machined abutments (TiGEN, ZrGEN), and various one- or two-piece designs in titanium or zirconia to restore chewing function.

The subject device encompasses eleven abutment types made primarily of Ti-6Al-4V ELI or zirconia, with various connection interfaces (internal hex, internal conical, external hex). Minor dimensional variations exist compared to predicates—some diameters, gingival heights, and post heights differ slightly—but all fall within or near the ranges of cleared reference devices. Materials, surface treatments (anodizing, machining), sterilization methods, and single-use status are identical to predicates.

ISO 10993-1 (biocompatibility); ISO 11137 and ISO 17665-1,2 (sterilization validation); ASTM F1980 (accelerated shelf-life testing); ISO 14801 (fatigue and performance testing); USP 39 <85> (endotoxin testing); FDA guidance on MR compatibility testing and Class II special controls for endosseous dental implants.

The subject device is substantially equivalent because it shares the same intended use, materials (Ti-6Al-4V ELI, zirconia, POM), manufacturing processes, sterilization methods, and fundamental design principles as predicate and reference devices. Minor dimensional variations in diameter, gingival height, and post height do not affect the device's fundamental function or safety and allow for more precise patient-specific treatment. Fatigue testing on worst-case models (angled abutments, Octa and ZrGEN abutments) and biocompatibility data leveraged from previously cleared devices with identical materials demonstrate safety and performance equivalence. Connection interfaces (hex, conical, octa) provide the same anti-rotational and functional characteristics across compatible implant systems.