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 Hager& Meisinger GmbH, Dentis Co., Ltd. and Stryker Leibinger GmbH & Co KG.
FDA 510(k) Cleared Screw, Fixation, Intraosseous Devices (Product Code DZL)
About Product Code DZL - Regulatory Context
510(k) Submission Activity
80 total 510(k) submissions under product code DZL since 1976, with 80 receiving FDA clearance (average review time: 149 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DZL have taken an average of 270 days to reach a decision - up from 139 days historically. Manufacturers should account for longer review timelines in current project planning.
DZL devices are reviewed by the Dental panel. Browse all Dental devices →