HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)

The HIOSSEN Pre-milled Abutment is a titanium dental implant abutment that provides support for prosthetic restorations such as crowns, bridges, and overdentures. It is customized at HIOSSEN-validated milling facilities using CAD/CAM technology based on patient-specific requirements, then sterilized and delivered to dentists for implantation onto compatible HIOSSEN dental implants.

The device is made of Ti-6Al-4V titanium alloy (ASTM F136) with a machined finish and conical connection to implants. It features a straight design (0° angulation), available in mini and regular connection sizes, with minimum wall thickness 0.7 mm, minimum post height 4.0 mm, maximum post height 17.5 mm, and maximum diameter 6.8 mm. Unlike the predicate, this abutment is milled at external validated facilities rather than manufactured in-house, but both use identical CAD/CAM manufacturing processes.

ISO 15223-1 (medical device symbols and labeling), ISO 20417 (information to be supplied by manufacturer), ISO 10993-1 (biocompatibility evaluation), ISO 17665-1 and ISO TS 17665-2 (moist heat sterilization), ANSI/AAMI ST79:2010 (steam sterilization guidance), and FDA guidance on MRI safety testing.

The device is substantially equivalent because it shares identical material (Ti-6Al-4V per ASTM F136), surface finish, conical connection type, and design parameters with the predicate ET SMARTFit Abutment (K123627). Although milling occurs at external validated facilities rather than in-house, these facilities use identical CAD/CAM processes and adhere to HIOSSEN's Quality Management System with periodic audits. Biocompatibility and sterilization data are leveraged from the cleared predicate device since sterilization methods and parameters are identical. The device is compatible with multiple 510(k)-cleared implant systems and uses already-cleared abutment screws.