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), Hager& Meisinger GmbH and Osteomed Corp..
FDA 510(k) Cleared Screw, Fixation, Intraosseous Devices (Product Code DZL)
About Product Code DZL - Regulatory Context
510(k) Submission Activity
81 total 510(k) submissions under product code DZL since 1976, with 81 receiving FDA clearance (average review time: 150 days).
Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 3 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - DZL Product Code
Recent submissions under DZL have taken an average of 259 days to reach a decision - up from 141 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 →