LONGY Implant and LONGY-N Implant

The LONGY and LONGY-N Implants are threaded titanium dental implants designed for splinted restorations in the upper jaw using a minimum of two implants to support fixed or removable prosthetic devices in patients with partial or full edentulism. They may be suitable for immediate loading when good primary stability is achieved and are available in diameters of 3.75 and 4.0 mm with lengths of 18, 20, 22, and 25 mm.

Both subject devices are bone-level implants made of titanium alloy Ti-6Al-4V ELI with an RBM surface treatment and internal hex connections, matching the primary predicate's design and sterilization via gamma irradiation. The LONGY-N variant includes two flat surfaces identical to reference device K151909. The subject devices offer the same diameter and length ranges as the predicate, with additional shorter length options as non-worst-case devices.

Fatigue testing per ISO 14801, biocompatibility per ISO 10993-5, ISO 10993-10, and ISO 10993-11, sterilization validation per ISO 11137-1 and ISO 11137-2, and MRI safety evaluation using published scientific literature on magnetically induced displacement force and torque.

The subject devices share identical material composition (Ti-6Al-4V ELI), surface treatment (RBM), sterilization method (gamma irradiation), and implant-to-abutment interface design with previously cleared predicates. They have equivalent intended use and indications for splinted maxillary restorations with immediate loading capability. Biocompatibility testing was leveraged from K151909 due to identical materials and processes, and performance strength testing demonstrated equivalence to the primary predicate. The design modifications (shorter lengths, LONGY-N flat surfaces) represent non-worst-case variations that do not compromise safety or effectiveness.