DESS® Dental Implants

DESS® Dental Implants are endosseous (bone-anchored) dental implants indicated for surgical placement in the upper or lower jaw of edentulous or partially edentulous patients to restore chewing function and esthetics. They support single or multi-unit tooth restorations, can be used with overdenture attachment systems, and permit immediate, early, or delayed loading techniques depending on primary stability.

The subject device implants are root-form, self-tapping, threaded implants made of unalloyed titanium (ASTM F67, ISO 5832-2) with an identical grit-blasted and double acid-etched (SLA) endosseous surface as the predicate. They feature a Morse taper (NEO GM) internal connection with 16° included angle and 2.99 mm diameter opening. Implant body diameters range 3.55–7.0 mm (labeled 3.5–7.0 mm) and lengths 7.9–17.9 mm (labeled 8–18 mm). Subject abutments are titanium alloy (Ti-6Al-4V, ASTM F136) with zirconium nitride coating, provided non-sterile for end-user sterilization.

ISO 14801 (mechanical testing), ISO 11137-1 and ISO 11137-2 (gamma irradiation sterilization validation to 10⁻⁶ SAL), ANSI/AAMI ST72 (bacterial endotoxin testing), ANSI/AAMI/ISO 17665-1 and TIR 17665-2 (moist heat sterilization validation), FDA guidance on MRI safety (T.O. Woods et al., Journal of Testing and Evaluation 2021).

The subject implants are substantially equivalent to primary predicate K212538 because both are root-form, bone-level, threaded implants manufactured from identical unalloyed titanium with identical SLA surface treatment and sterilized by the same gamma irradiation method. The subject device implant diameter range (3.55–7.0 mm) encompasses the predicate range (3.0–5.5 mm) and overlaps with reference device K143353 (3.0–7.0 mm); implant lengths are substantially equivalent (7.9–17.9 mm vs. predicate 7–18 mm). Subject abutments are substantially equivalent to reference K242340 in design, material composition (Ti-6Al-4V), identical NEO GM connection, and non-sterile provision with validated moist heat sterilization. No differences in technological characteristics raise new questions of safety or effectiveness.