S.I.N. Dental Implant System

The S.I.N. Dental Implant System is an endosseous dental implant intended for placement in the upper or lower jaw to support single-unit or multi-unit tooth restorations. The implants can be immediately loaded when good primary stability is achieved. Implants 18–24 mm long may be tilted up to 30°, subject to specific splinting requirements.

The subject device features Versalis S and Versalis S Plus implant lines with a 16° internal morse taper abutment connection. Both are manufactured from unalloyed titanium (ASTM F67) with double acid-etched surface treatment; the Plus line adds hydroxyapatite (HA) nanocoating. Available diameters range 3.5–7.0 mm and lengths 8.5–24 mm, matching predicate sizing.

ISO 11137-1, ISO 11137-2 (sterilization validation); ISO 17665-1, ISO 17665-2 (steam sterilization); ANSI/AAMI ST72 (LAL bacterial endotoxin); ASTM F1980, F1929, F88/F88M (shelf life and seal integrity); ISO 10993-1 (biocompatibility); ASTM F2052, F2213, F2182, F2119, F2119 (MR safety); ISO 14801 (fatigue testing).

The subject implants are substantially equivalent because they use identical material (unalloyed titanium ASTM F67), identical surface treatments (acid-etched and acid-etched plus HA nanocoating), identical manufacturing processes and facilities, and identical sterilization methods as the primary and additional predicates. The 16° morse taper interface, size range, and indications for use are the same as predicate K222231 and K170392. Testing data demonstrates performance meeting or exceeding predicate devices under identical or more stringent conditions.