T3 Pro Implants– ZimVie Packaging System

The T3 Pro Implants are titanium dental implants designed for surgical placement in the upper or lower jaw to replace missing teeth. They provide attachment points for single tooth restorations, multiple teeth, and full dentures, and can be loaded immediately or after a healing period.

The subject device is identical in material (commercially pure titanium per ASTM F67), design, and operating principle to the primary predicate device K213672. The only change is the new ZimVie Packaging System—the internal titanium sleeve, polypropylene inner tray, and Tyvek lid remain unchanged; only the outer thermoformed tray, labels, and cardboard box were redesigned to standardize packaging across ZimVie implant families.

ISO 13004, ISO 11137 (parts 1, 2, 3) for gamma sterilization validation; ASTM F1980 for shelf-life aging; ISTA 3A and ASTM D4169 for distribution and environmental conditioning; ISO 10993-1 for biocompatibility; ASTM F2503-13 for MR Safety testing; ISO 11737-3 for bacterial endotoxin testing via LAL assay.

The subject device achieves substantial equivalence because the implant itself is materially and functionally identical to the predicate device K213672 in all critical respects: same titanium material, same design, same indications for use, and same operating principle. The packaging modifications do not affect the device's safety or effectiveness—the implant remains in direct contact with the same inner tray configuration, sterilization remains gamma irradiation (22.5–38 kGy), and all protective elements maintain their function. The shortened shelf-life (2 years vs. 5 years) was established through validated aging and packaging studies, representing a conservative approach that does not raise new safety concerns.