LOCATOR® Angled Abutment

The LOCATOR Angled Abutment is a dental implant abutment used to attach full or partial fixed and removable restorations to endosseous dental implants to restore chewing function. This submission expands the product's compatibility to include new implant systems from BioHorizons (Tapered 3.0, CONELOG platforms, and Tapered Pro/Short Conical variants) and Implant Direct (Legacy 3, 3.0mmD).

The device is made of Ti-6Al-4V ELI titanium with a TiN coating, features a 15° angled abutment design, has a cuff height of 2.5–7.5 mm, and uses conical and internal hex connections. It is identical in material, design, and sterilization method (moist heat end-user sterilization) to the predicate device K250721, with compatibility verified through engineering analysis against OEM implant specifications.

ASTM F136 (titanium alloy), ASTM F1044 and ASTM F1147 (TiN coating), ASTM F2052-21, F2213-17, F2182-19, and F2119-07 (MR compatibility), and ISO 10993-1 and ISO 10993-5 (biocompatibility). ISO 14801 fatigue testing parameters were verified as equivalent to OEM cleared abutment specifications.

The subject device is substantially equivalent because it is a modification of the manufacturer's own cleared device K250721, sharing identical intended use, materials, manufacturing processes, design principles, and prosthetic attachment features. Compatibility with new implant systems was demonstrated through engineering analysis verifying critical tolerances against OEM specifications, with no new worst-case scenarios identified. Previously conducted testing on MR compatibility, biocompatibility, packaging, sterilization, and TiN coating performance was leveraged to establish equivalence.