Bonafix Implant Abutments

Bonafix Implant Abutments are dental prosthetic components designed to connect dental implants to tooth crowns or bridges in patients missing one or more teeth. The system includes three types of abutments (Temporary, Multi-Unit Straight, and Titanium Base) and is compatible with 16 different endosseous implant platforms from five manufacturers. All components are provided non-sterile and require end-user steam sterilization before use.

The subject device uses titanium alloy (Ti-6Al-4V, ASTM F136) for abutment bodies and screws, with zirconia (ISO 13356) superstructures for the TiBase design. Design parameters include minimum post height of 4.0 mm, maximum gingival height of 5.0 mm, and 0° angulation (no angular correction). Platform diameters range from 3.5–6.3 mm. All characteristics are identical or substantially similar to the predicate device K221673, differing only in the newly added compatible implant systems.

ISO 17665-1 for sterilization validation (SAL 1×10⁻⁶), ISO 10993-5 for cytotoxicity testing, ASTM F136 for titanium alloy specification, and ISO 13356 for zirconia material. FDA Guidance on Class II Special Controls for endosseous dental implants and abutments, and FDA Guidance on MRI safety testing were applied.

Substantial equivalence is supported because the subject device has identical intended use (supporting single or multi-unit prostheses), uses the same operating principles and materials as the predicate, incorporates the same abutment design categories and sterilization processes, and non-clinical testing (sterilization, cytotoxicity, dimensional compatibility analysis, and MRI review) demonstrates equivalent safety and performance. The primary difference—expanded compatible implant systems—does not affect safety or efficacy.