CeraRoot TL Implant System (TL)

The CeraRoot TL Implant System is a two-piece ceramic dental implant made of Y-TZP zirconium dioxide for surgical placement in the upper or lower jaw to support fixed prosthetic restorations (artificial teeth). It is designed for single or multiple tooth replacements and is particularly indicated for patients with metal allergies. The implants are placed in immediate or delayed tooth extractions and are intended for delayed loading.

The CeraRoot TL differs from its one-piece primary predicate by being a two-piece tissue-level design with separate cemented abutments (available in 4.3 and 5.8 mm heights). Both the implant and abutments are Y-TZP ceramic with acid-etched surfaces. Available implant models (34TL, 21TL, 16TL) span 8–14 mm lengths. The two-piece design introduces an internal heart-shaped anti-rotation feature and uses temporary PTFE sealing during the healing phase, unlike the one-piece predicate.

ISO 13356 (Y-TZP ceramic materials), ISO 14801 (dynamic fatigue testing for dental implants), ISO 10993-1 and ISO 10993-5 (biocompatibility and cytotoxicity), ISO 11135 (ethylene oxide sterilization validation), ISO 11607-1 and ISO 11607-2 (packaging validation), ISO 17665 (moist heat sterilization for non-sterile components), EN 1642 (dental implants), and ISO 6872 (ceramic materials).

The subject device shares the same Y-TZP material, manufacturing (milling and sintering), acid-etch surface finish, sterilization method (ethylene oxide), and packaging as the primary predicate. Differences arising from the two-piece design (abutments, internal anti-rotation feature, temporary sealing) are addressed by reference devices (K190406, K132881, K163043, K180477) that have already been FDA-cleared and demonstrate these same technologies are safe and effective. Fatigue testing per ISO 14801 confirms the CeraRoot TL meets existing requirements and acceptance criteria. No new risks requiring additional validation were identified.