FDA Product Code DZB: Headgear, Extraoral, Orthodontic
Leading manufacturers include Ita.O Italian Orthodontic System S.R.L..
36
Total
36
Cleared
99d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Headgear, Extraoral, Orthodontic Devices (Product Code DZB)
36 devices
About Product Code DZB - Regulatory Context
510(k) Submission Activity
36 total 510(k) submissions under product code DZB since 1977, with 36 receiving FDA clearance (average review time: 99 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
DZB devices are reviewed by the Dental panel. Browse all Dental devices →