FDA Product Code DZJ: Driver, Wire, And Bone Drill, Manual
Leading manufacturers include Techfit Digital Surgery, Inc. and Materialise NV.
FDA 510(k) Cleared Driver, Wire, And Bone Drill, Manual Devices (Product Code DZJ)
About Product Code DZJ - Regulatory Context
510(k) Submission Activity
31 total 510(k) submissions under product code DZJ since 1976, with 31 receiving FDA clearance (average review time: 190 days).
Submission volume has declined in recent years - 2 submissions in the last 24 months compared to 5 in the prior period.
FDA Review Time
Recent submissions under DZJ have taken an average of 110 days to reach a decision - down from 196 days historically, suggesting improved FDA processing for this classification.
DZJ devices are reviewed by the Dental panel. Browse all Dental devices →