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 Dentis Co., Ltd., Stryker Leibinger GmbH & Co KG and KLS-Martin L.P..
List of Screw, Fixation, Intraosseous devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Screw, Fixation, Intraosseous devices (product code DZL). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →