Straumann® PURE Ceramic Implants

The Straumann® PURE Ceramic Implants are endosseous dental implants made of yttrium-stabilized zirconium dioxide (Y-TZP) used to restore single tooth gaps or multiple missing teeth in edentulous or partially edentulous jaws. They are available in two designs (monotype and two-piece) with diameters of 3.3 mm and 4.1 mm, and lengths of 8, 10, 12, and 14 mm, with the smaller 3.3 mm diameter recommended for anterior teeth only.

The devices feature a sand-blasted, large-grit, acid-etched (ZLA®) surface treatment with 0.8 mm thread pitch and a 1.8 mm machined transmucosal neck. They maintain identical material composition, surface treatment, implant diameters, lengths, straight cylindrical design, and thread pitch to the primary predicate K171769. Sterilization is by ethylene oxide, matching predicate devices.

ISO 14801 (dynamic loading test for endosseous dental implants), ISO 10993-1 (biological evaluation of medical devices), ISO 11135 (sterilization of health care products by ethylene oxide), and ASTM F1980 (packaging stability and shelf-life testing). Testing also followed FDA guidance on Class II Special Controls for root-form endosseous dental implants.

Substantial equivalence is established because the subject device is identical to the primary predicate K171769 in all material, design, and technological characteristics including Y-TZP composition, ZLA® surface, dimensions, thread pitch, and sterilization method. The submission addresses only a change in raw material supplier while maintaining identical performance and safety profiles demonstrated through comparative dynamic fatigue testing, biological assessment, and reference to prior sterilization and shelf-life validation data from predicates.