FDA Product Code EKZ: Unit, Electrosurgical, And Accessories, Dental
Leading manufacturers include J. Morita USA, Inc., Coulter Electronics, Inc. and Parkell, Inc..
19
Total
19
Cleared
135d
Avg days
1983
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Unit, Electrosurgical, And Accessories, Dental Devices (Product Code EKZ)
19 devices
Cleared
Aug 03, 2022
Root ZX3
J. Morita USA, Inc.
Dental
278d
Cleared
Jul 30, 1996
ARTHROCARE DENTAL ELECTROSURGERY SYSTEM
Arthrocare Corp.
Dental
36d
Cleared
Jun 06, 1995
SENSIMATIC 500SE
Parkell, Inc.
Dental
137d
Cleared
May 16, 1983
DIFF 4 SYSTEM
Coulter Electronics, Inc.
Hematology
95d
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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.