LOCATOR Angled Abutment

The LOCATOR Angled Abutment is a dental implant abutment component designed to attach full or partial fixed and removable restorations to endosseous (bone-anchored) dental implants. This submission expands the product line to support multiple OEM implant systems: Straumann BLX, Zimmer (ZimVie) TSV, Nobel RP/NP, and Neodent Grand Morse implants, allowing dentists to restore chewing function with angle-corrected prosthetics.

The subject device shares identical design features to its predicate: a 15-degree angled abutment made of Ti-6Al-4V ELI with titanium nitride (TiN) surface coating, abutment heights of 2.5–7.5 mm, and the same fundamental prosthetic attachment interface for LOCATOR FIXED and LOCATOR Attachment Systems. The primary difference is expanded implant/abutment interface compatibility with three additional OEM systems verified through reverse engineering and ISO 14801 fatigue testing.

ISO 14801:2016 (fatigue testing), ASTM F1044 and ASTM F1147 (TiN coating performance), ASTM F2052-21, ASTM F2213-17, ASTM F2182-19, ASTM F2119-07 (MR compatibility), and ISO 10993-1 and ISO 10993-5 (biocompatibility and cytotoxicity).

The device demonstrates substantial equivalence because it employs identical materials, manufacturing processes, design geometry, and prosthetic attachment features as the predicate device (K233587). The sole modification is adapting the abutment/implant interface to fit OEM implant platforms from Zimmer, Nobel, and Neodent through precision reverse engineering and validation testing. Since the fundamental intended use, operating principles, and critical performance characteristics remain unchanged, and the expanded compatibility was verified to function safely and effectively with the smallest-diameter implants in each system, the device poses no new risks or operational differences.