FDA Product Code EKZ: Unit, Electrosurgical, And Accessories, Dental
Leading manufacturers include J. Morita USA, Inc..
19
Total
19
Cleared
135d
Avg days
1983
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Unit, Electrosurgical, And Accessories, Dental Devices (Product Code EKZ)
19 devices
About Product Code EKZ - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code EKZ since 1983, with 19 receiving FDA clearance (average review time: 135 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
EKZ devices are reviewed by the Dental panel. Browse all Dental devices →