Leone Orthodontic Implant TAD (Temporary Anchorage Device)

The Leone Orthodontic Implant TAD is a titanium miniscrew designed to serve as a fixed anchorage point for orthodontic appliances in adolescents over 12 years old and adults. The device is temporarily implanted in maxillary or mandibular bone to facilitate tooth movement and is removed after orthodontic treatment is complete; screws are single-use only.

The Leone TAD is an 8 mm self-drilling titanium alloy screw (ISO 5832-3/ASTM F136) with a 2.0 mm body diameter and right-hand thread, supplied sterile by gamma irradiation in a plastic vial inside a sealed blister. The predicate PSM LOMAS/BENEFIT Screws have similar design and materials but are available in lengths of 7, 9, 11, 13, and 15 mm; the Leone's 8 mm length falls within this range.

ASTM F543 (Metallic Medical Bone Screws), ISO 19023 (Orthodontic Anchor Screws), ISO 5832-3 (Wrought titanium alloy), ISO 10993-1/5/12 (Biocompatibility), ISO 11137-1/2/3 (Sterilization validation), and FDA Biocompatibility Guidance.

Both devices share identical indications for use, same titanium alloy material, same anatomical site, identical design principles (self-drilling, right-hand thread), equivalent sterilization method, and comparable body diameter. The Leone's 8 mm length is within the predicate's range, and nonclinical performance testing (insertion, failure torque, pull-out, bending, and surface analysis) showed comparable outcomes between subject and predicate devices across all assessed endpoints, demonstrating functional and performance equivalence.