DESS Dental Smart Solutions

DESS Dental Smart Solutions is a dental implant abutment system designed to support prosthetic restorations, particularly overdentures, in the upper or lower jaw. The system consists of titanium abutments with a zirconium nitride coating, retention inserts made of nylon, and titanium denture housings that allow for resilient attachment of prostheses to endosseous dental implants.

The subject device adds an 18° angled abutment design and expands compatibility to additional implant platforms and gingival heights compared to the predicate K251547. The abutments are made of titanium alloy (Ti 6Al-4V ELI) with zirconium nitride coating (2–3 µm thickness), offer diameters of 2.9–5.7 mm and gingival heights of 0.5–6 mm, and accommodate 18°/36° divergence allowance. The system uses the same nylon inserts and denture housing materials as the predicate.

ISO 17665-1 and ISO 17665-2 (sterilization validation), FDA guidance on testing and labeling medical devices for safety in the magnetic resonance environment, and reverse engineering analysis of OEM implant bodies and components. Fatigue testing was performed on OEM implant bodies with abutments at worst-case angled conditions.

The subject device is substantially equivalent to predicate K251547 because it has identical indications for use, the same intended purpose of supporting prostheses for functional rehabilitation, identical materials and coronal geometry for overdenture retention, and the same sterilization methods. The addition of angled configurations and expanded implant platform compatibilities do not alter the fundamental technology or mechanism of action, which remains identical to the predicate and similar to reference device K233587.