LOCATOR® Angled Abutment

The LOCATOR Angled Abutment is a dental implant abutment made of titanium alloy (Ti-6Al-4V ELI) with titanium nitride coating. It is designed for attachment of fixed or removable dental restorations retained by endosseous implants to restore chewing function. This submission expands the device's compatibility to new implant systems from Implant Direct, BioHorizons, and Implant Logistics while maintaining the same 15-degree angled interfacing feature.

The subject device shares identical materials (Ti-6Al-4V ELI with TiN coating), abutment height range (2.5-7.5 mm), 15-degree angle design, and internal connection types with the predicate device K243272. Key differences are expanded implant platform compatibility across multiple manufacturers (Straumann, Nobel, Neodent, ZimVie, Implant Direct, BioHorizons, Implant Logistics) with various connection types (Internal Hex, Conical, Conical Taper, Grand Morse Taper).

ISO 14801:2016 (fatigue testing), ASTM F136 (titanium alloy material), ASTM F1044 and F1147 (TiN coating performance), ASTM F2052-21, F2213-17, F2182-19, F2119-07 (MR compatibility), ISO 10993-1 and ISO 10993-5 (biocompatibility and cytotoxicity).

The device is substantially equivalent because it modifies the manufacturer's own cleared predicate device (K243272) using identical materials, manufacturing processes, and fundamental 15-degree angled design with the same prosthetic attachment features. Engineering analysis and functional verification confirmed that compatibility with additional implant systems from Implant Direct and BioHorizons does not create new worst-case scenarios, and the Implant Logistics abutments were designed to OEM specifications already cleared under K173701 and K102822, requiring no new worst-case testing. Biocompatibility and MR testing previously performed on similar Ti-6Al-4V components with comparable features demonstrate the subject device creates no new worst-case safety concerns.