LOCATOR® Angled Abutment

The LOCATOR Angled Abutment is a dental implant abutment (connector) that attaches full or partial fixed and removable dental restorations to endosseous implants to restore chewing function. This 510(k) expands compatibility to new Hiossen implant systems (EK, ET Mini, ET Regular, and ET Ultra-Wide) while maintaining the same design and materials as the previously cleared predicate device.

The device is a 15° angled abutment made of titanium alloy Ti-6Al-4V ELI with a TiN coating, featuring conical and internal hex connections. It has an abutment cuff height of 2.5–7.5 mm and is sterilized via moist heat by the end user, identical to the predicate device K252944. The new versions are designed to replicate critical specifications from Hiossen's OEM drawings to ensure equivalent interface performance with their implant systems.

ASTM F136 (titanium alloy composition), ASTM F1044 and ASTM F1147 (TiN coating performance), ISO 10993-1 and ISO 10993-5 (biocompatibility and cytotoxicity), ASTM F2052-21, F2213-17, F2182-19, F2119-07 (MR compatibility), and ISO 14801 (fatigue testing reference for critical design parameters).

The subject device demonstrates substantial equivalence to predicate K252944 because it shares identical intended use, materials, manufacturing processes, and fundamental design with identical prosthetic attachment features. Compatibility with Hiossen implants was established by replicating the OEM's design specifications and critical ISO 14801 fatigue parameters, creating no new worst-case scenarios. Existing test data on packaging, sterilization, biocompatibility, and MR safety were leveraged through engineering analysis confirming no new worst-case conditions.