ISO Abutment

The ISO Abutment is a titanium dental implant abutment placed into endosseous dental implants to provide support for prosthetic restorations. It is designed for use with overdentures or partial dentures retained by implants in the mandible or maxilla, and is compatible with implants from multiple third-party manufacturers including Osstem, Medimecca, Dentium, BioHorizons, Surgikor, Megagen, Dentis, Neobiotech, Straumann, and 3I.

The ISO Abutment is made from Titanium grade Ti-6Al-4V ELI (ASTM F-136) with TiN coating applied to the head portion. It has a gingival height range of 1-6 mm, post height of 1.5 mm, and 0° angulation. The device uses autoclave sterilization and is fundamentally similar in design, material, surface treatment, and sterilization method to the predicate device, with the primary difference being compatibility with a broader range of third-party manufacturer implants.

ISO 17665-1 & 2 (sterilization validation); ISO 10993-5 (cytotoxicity), ISO 10993-10 (oral mucosa irritation and skin sensitization), ISO 10993-11 (acute and sub-chronic systemic toxicity), ISO 10993-3 and 10993-33 (bacterial reverse mutation); ASTM F1044, F1147, F1160 (TiN coating); ASTM F2052, F2213, F2182, F2119 (MRI safety assessment).

The subject device shares the same intended use as the predicate (Kerator K112787) and employs identical operating principles, design approach, material composition, and sterilization method. Reverse engineering analysis and cross-section validation confirmed compatibility with multiple third-party implants without raising new safety or effectiveness concerns. The expanded implant compatibility represents only a difference in scope of use, not a fundamental change in how the device functions, and is supported by reference devices with similar dimensional variations.