FDA Product Code DZL: Screw, Fixation, Intraosseous

Under FDA product code DZL, intraosseous fixation screws are cleared for bone fixation in dental and maxillofacial surgery.

These titanium or resorbable screws are used to stabilize osteotomized or fractured bone segments of the jaws and craniofacial skeleton, providing rigid fixation that allows primary bone healing without movement at the repair site.

DZL devices are Class II medical devices, regulated under 21 CFR 872.4880 and reviewed by the FDA Dental panel.

Leading manufacturers include Synthes (Usa), Biomet, Inc. and Osstem Implant Co., Ltd..